Trial Outcomes & Findings for Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances (NCT NCT06349759)

NCT ID: NCT06349759

Last Updated: 2026-08-18

Results Overview

This outcome measure will investigate the percent of subjects with an increase of at least 15 ETDRS letters read (≥ 3 lines) in the study eye in mLCVA compared to baseline (Day 1 pre-dose) at Day 15 in an effort to evaluate the efficacy of POS to improve mLCVA in subjects with post-refractive surgery visual disturbances.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

200 participants

Primary outcome timeframe

15 Days

Results posted on

2026-08-18

Participant Flow

Participant milestones

Participant milestones
Measure	0.75% Phentolamine Ophthalmic Solution 0.75% phentolamine ophthalmic solution: Daily dosing	Phentolamine Ophthalmic Solution Vehicle Drug: Placebo, Placebo: Once daily dosing
Overall Study STARTED	100	100
Overall Study COMPLETED	78	87
Overall Study NOT COMPLETED	22	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.75% Phentolamine Ophthalmic Solution n=99 Participants 0.75% phentolamine ophthalmic solution: Daily dosing	Phentolamine Ophthalmic Solution Vehicle n=100 Participants Drug: Placebo, Placebo: Once daily dosing	Total n=199 Participants Total of all reporting groups
Age, Continuous	45.3 Years STANDARD_DEVIATION 9.86 • n=298 Participants	45.5 Years STANDARD_DEVIATION 10.92 • n=102 Participants	45.4 Years STANDARD_DEVIATION 10.38 • n=400 Participants
Sex: Female, Male Female	69 Participants n=298 Participants	35 Participants n=102 Participants	104 Participants n=400 Participants
Sex: Female, Male Male	30 Participants n=298 Participants	65 Participants n=102 Participants	95 Participants n=400 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=298 Participants	0 Participants n=102 Participants	1 Participants n=400 Participants
Race (NIH/OMB) Asian	10 Participants n=298 Participants	9 Participants n=102 Participants	19 Participants n=400 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=298 Participants	0 Participants n=102 Participants	1 Participants n=400 Participants
Race (NIH/OMB) Black or African American	7 Participants n=298 Participants	8 Participants n=102 Participants	15 Participants n=400 Participants
Race (NIH/OMB) White	78 Participants n=298 Participants	81 Participants n=102 Participants	159 Participants n=400 Participants
Race (NIH/OMB) More than one race	2 Participants n=298 Participants	2 Participants n=102 Participants	4 Participants n=400 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=298 Participants	0 Participants n=102 Participants	0 Participants n=400 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=298 Participants	9 Participants n=102 Participants	22 Participants n=400 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	86 Participants n=298 Participants	91 Participants n=102 Participants	177 Participants n=400 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=298 Participants	0 Participants n=102 Participants	0 Participants n=400 Participants
Study eye Right eye	49 Participants n=298 Participants	45 Participants n=102 Participants	94 Participants n=400 Participants
Study eye Left eye	50 Participants n=298 Participants	55 Participants n=102 Participants	105 Participants n=400 Participants
Irides type Light	47 Participants n=298 Participants	47 Participants n=102 Participants	94 Participants n=400 Participants
Irides type Dark	52 Participants n=298 Participants	53 Participants n=102 Participants	105 Participants n=400 Participants
Mesopic Low-Contrast Best-Corrected Distance Visual Acuity (mLCVA) in the Study Eye	19.2 Letters Read STANDARD_DEVIATION 6.00 • n=298 Participants	17.8 Letters Read STANDARD_DEVIATION 6.68 • n=102 Participants	18.5 Letters Read STANDARD_DEVIATION 6.37 • n=400 Participants
Mesopic Low-Contrast Best-Corrected Distance Visual Acuity (mLCVA) in the Fellow Eye	22.7 Letters Read STANDARD_DEVIATION 7.09 • n=298 Participants	21.7 Letters Read STANDARD_DEVIATION 6.67 • n=102 Participants	22.2 Letters Read STANDARD_DEVIATION 6.88 • n=400 Participants
Mesopic Low-Contrast Best-Corrected Distance Visual Acuity (mLCVA) Binocular	28.0 Letters Read STANDARD_DEVIATION 6.25 • n=298 Participants	27.2 Letters Read STANDARD_DEVIATION 5.82 • n=102 Participants	27.6 Letters Read STANDARD_DEVIATION 6.04 • n=400 Participants
Mesopic High-Contrast Best-Corrected Distance Visual Acuity (mHCVA) in the Study Eye	49.5 Letters Read STANDARD_DEVIATION 5.47 • n=298 Participants	48.6 Letters Read STANDARD_DEVIATION 6.31 • n=102 Participants	49.0 Letters Read STANDARD_DEVIATION 5.91 • n=400 Participants
Mesopic High-Contrast Best-Corrected Distance Visual Acuity (mHCVA) in the Fellow Eye	50.7 Letters Read STANDARD_DEVIATION 5.81 • n=298 Participants	49.6 Letters Read STANDARD_DEVIATION 6.70 • n=102 Participants	50.2 Letters Read STANDARD_DEVIATION 6.28 • n=400 Participants
Mesopic High-Contrast Best-Corrected Distance Visual Acuity (mHCVA) Binocular	53.6 Letters Read STANDARD_DEVIATION 4.70 • n=298 Participants	52.4 Letters Read STANDARD_DEVIATION 5.77 • n=102 Participants	53.0 Letters Read STANDARD_DEVIATION 5.29 • n=400 Participants
Mesopic Pupil Diameter (PD) in the Study Eye	5.985 millimeters STANDARD_DEVIATION 4.70 • n=298 Participants	5.849 millimeters STANDARD_DEVIATION 0.6820 • n=102 Participants	5.917 millimeters STANDARD_DEVIATION 0.7367 • n=400 Participants
Mesopic Pupil Diameter (PD) in the Fellow Eye	5.941 millimeters STANDARD_DEVIATION 0.8476 • n=298 Participants	5.779 millimeters STANDARD_DEVIATION 0.6758 • n=102 Participants	5.859 millimeters STANDARD_DEVIATION 0.7685 • n=400 Participants
Intraocular Pressure (IOP) in the Study Eye	14.1 mmHg STANDARD_DEVIATION 2.58 • n=298 Participants	14.6 mmHg STANDARD_DEVIATION 2.60 • n=102 Participants	14.3 mmHg STANDARD_DEVIATION 2.60 • n=400 Participants
Intraocular Pressure (IOP) in the Fellow Eye	14.3 mmHg STANDARD_DEVIATION 2.58 • n=298 Participants	14.2 mmHg STANDARD_DEVIATION 2.66 • n=102 Participants	14.2 mmHg STANDARD_DEVIATION 2.62 • n=400 Participants

PRIMARY outcome

Timeframe: 15 Days

Population: The number of subjects whose data is analyzed for a particular outcome depends on how many subjects had an assessment at each particular timepoint of interest.

This outcome measure will investigate the percent of subjects with an increase of at least 15 ETDRS letters read (≥ 3 lines) in the study eye in mLCVA compared to baseline (Day 1 pre-dose) at Day 15 in an effort to evaluate the efficacy of POS to improve mLCVA in subjects with post-refractive surgery visual disturbances.

Outcome measures

Outcome measures
Measure	Phentolamine Ophthalmic Solution Vehicle n=98 Participants Drug: Placebo, Placebo: Once daily dosing	0.75% Phentolamine Ophthalmic Solution n=98 Participants 0.75% phentolamine ophthalmic solution: Daily dosing
Percentage of Subjects With ≥ 15 Letters (3 Lines) Improvement in mLCVA in the Study Eye at Day 15 Compared to Baseline	9 Participants	17 Participants

SECONDARY outcome

Timeframe: 6 Weeks

Population: The number of subjects whose data is analyzed for a particular outcome depends on how many subjects had an assessment at each particular timepoint of interest.

This outcome measure will investigate the percentage of subjects with ≥ 10 and ≥ 15 ETDRS letters improvement in mLCVA compared to baseline at Days 3, 8, and 15 (≥ 10 ETDRS letters only) and Week 6.

Outcome measures

Outcome measures
Measure	Phentolamine Ophthalmic Solution Vehicle n=99 Participants Drug: Placebo, Placebo: Once daily dosing	0.75% Phentolamine Ophthalmic Solution n=98 Participants 0.75% phentolamine ophthalmic solution: Daily dosing
Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in mLCVA Compared to Baseline (Day 1 Pre-dose) at Days 3, 8, and 15 (≥ 10 ETDRS Letters Only) and Week 6 Day 3: >= 15 Letters (>= 3 Lines)	12 Participants	17 Participants
Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in mLCVA Compared to Baseline (Day 1 Pre-dose) at Days 3, 8, and 15 (≥ 10 ETDRS Letters Only) and Week 6 Day 3: >= 10 Letters (>= 2 Lines)	38 Participants	57 Participants
Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in mLCVA Compared to Baseline (Day 1 Pre-dose) at Days 3, 8, and 15 (≥ 10 ETDRS Letters Only) and Week 6 Day 8: >= 15 Letters (>= 3 Lines)	8 Participants	16 Participants
Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in mLCVA Compared to Baseline (Day 1 Pre-dose) at Days 3, 8, and 15 (≥ 10 ETDRS Letters Only) and Week 6 Day 8: >= 10 Letters (>= 2 Lines)	35 Participants	59 Participants
Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in mLCVA Compared to Baseline (Day 1 Pre-dose) at Days 3, 8, and 15 (≥ 10 ETDRS Letters Only) and Week 6 Day 15: >= 15 Letters (>= 3 Lines)	9 Participants	17 Participants
Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in mLCVA Compared to Baseline (Day 1 Pre-dose) at Days 3, 8, and 15 (≥ 10 ETDRS Letters Only) and Week 6 Day 15: >= 10 Letters (>= 2 Lines)	42 Participants	51 Participants
Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in mLCVA Compared to Baseline (Day 1 Pre-dose) at Days 3, 8, and 15 (≥ 10 ETDRS Letters Only) and Week 6 Week 6: >= 15 Letters (>= 3 Lines)	14 Participants	16 Participants
Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in mLCVA Compared to Baseline (Day 1 Pre-dose) at Days 3, 8, and 15 (≥ 10 ETDRS Letters Only) and Week 6 Week 6: >= 10 Letters (>= 2 Lines)	38 Participants	42 Participants

SECONDARY outcome

Timeframe: 3 hours

Population: The number of subjects whose data is analyzed for a particular outcome depends on how many subjects had an assessment at each particular timepoint of interest.

This outcome measure will investigate the mean and change from baseline in mLCVA at 0.5, 1, and 3 hours post-dose on Day 1.

Outcome measures

Outcome measures
Measure	Phentolamine Ophthalmic Solution Vehicle n=100 Participants Drug: Placebo, Placebo: Once daily dosing	0.75% Phentolamine Ophthalmic Solution n=99 Participants 0.75% phentolamine ophthalmic solution: Daily dosing
Mean and Change From Baseline in mLCVA at 0.5, 1, and 3 Hours Post-dose on Day 1 Day 1, 3 Hours Post-dose	6.65 Letters Read Standard Deviation 0.552	10.70 Letters Read Standard Deviation 0.554
Mean and Change From Baseline in mLCVA at 0.5, 1, and 3 Hours Post-dose on Day 1 Day 1, 1 Hour Post-dose	6.67 Letters Read Standard Deviation 0.526	9.70 Letters Read Standard Deviation 0.529
Mean and Change From Baseline in mLCVA at 0.5, 1, and 3 Hours Post-dose on Day 1 Day 1, 0.5 Hour Post-dose	5.76 Letters Read Standard Deviation 0.568	6.87 Letters Read Standard Deviation 0.571

SECONDARY outcome

Timeframe: 6 Weeks

Population: The number of subjects whose data is analyzed for a particular outcome depends on how many subjects had an assessment at each particular timepoint of interest.

This outcome measure will investigate the percentage of subjects with ≥ 10 and ≥ 15 ETDRS letters improvement in mesopic high-contrast best-corrected distance visual acuity (mHCVA) compared to baseline at Days 3, 8, and 15 and Week 6.

Outcome measures

Outcome measures
Measure	Phentolamine Ophthalmic Solution Vehicle n=99 Participants Drug: Placebo, Placebo: Once daily dosing	0.75% Phentolamine Ophthalmic Solution n=98 Participants 0.75% phentolamine ophthalmic solution: Daily dosing
Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in Mesopic High-contrast Best-corrected Distance Visual Acuity (mHCVA) Compared to Baseline (Day 1 Pre-Dose) at Days 3, 8, and 15 and Week 6 Week 6: >= 15 Letters (>= 3 Lines)	3 Participants	5 Participants
Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in Mesopic High-contrast Best-corrected Distance Visual Acuity (mHCVA) Compared to Baseline (Day 1 Pre-Dose) at Days 3, 8, and 15 and Week 6 Week 6: >= 10 Letters (>= 2 Lines)	8 Participants	12 Participants
Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in Mesopic High-contrast Best-corrected Distance Visual Acuity (mHCVA) Compared to Baseline (Day 1 Pre-Dose) at Days 3, 8, and 15 and Week 6 Day 3: >= 15 Letters (>= 3 Lines)	1 Participants	4 Participants
Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in Mesopic High-contrast Best-corrected Distance Visual Acuity (mHCVA) Compared to Baseline (Day 1 Pre-Dose) at Days 3, 8, and 15 and Week 6 Day 3: >= 10 Letters (>= 2 Lines)	2 Participants	10 Participants
Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in Mesopic High-contrast Best-corrected Distance Visual Acuity (mHCVA) Compared to Baseline (Day 1 Pre-Dose) at Days 3, 8, and 15 and Week 6 Day 8: >= 15 Letters (>= 3 Lines)	2 Participants	4 Participants
Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in Mesopic High-contrast Best-corrected Distance Visual Acuity (mHCVA) Compared to Baseline (Day 1 Pre-Dose) at Days 3, 8, and 15 and Week 6 Day 8: >= 10 Letters (>= 2 Lines)	5 Participants	9 Participants
Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in Mesopic High-contrast Best-corrected Distance Visual Acuity (mHCVA) Compared to Baseline (Day 1 Pre-Dose) at Days 3, 8, and 15 and Week 6 Day 15: >= 15 Letters (>= 3 Lines)	2 Participants	4 Participants
Percentage of Subjects With ≥ 10 and ≥ 15 ETDRS Letters Improvement in Mesopic High-contrast Best-corrected Distance Visual Acuity (mHCVA) Compared to Baseline (Day 1 Pre-Dose) at Days 3, 8, and 15 and Week 6 Day 15: >= 10 Letters (>= 2 Lines)	9 Participants	10 Participants

SECONDARY outcome

Timeframe: 6 Weeks

Population: The number of subjects whose data is analyzed for a particular outcome depends on how many subjects had an assessment at each particular timepoint of interest.

This outcome measure will investigate the mean and change from baseline in mLCVA and mHCVA at Days 3, 8, and 15 and Week 6.

Outcome measures

Outcome measures
Measure	Phentolamine Ophthalmic Solution Vehicle n=99 Participants Drug: Placebo, Placebo: Once daily dosing	0.75% Phentolamine Ophthalmic Solution n=98 Participants 0.75% phentolamine ophthalmic solution: Daily dosing
Mean and Change From Baseline (Day 1 Pre-dose) in mLCVA and mHCVA at Days 3, 8, and 15 and Week 6 Week 6, Change from Baseline in mLCVA	8.05 Letters Read Standard Deviation 0.624	8.87 Letters Read Standard Deviation 0.629
Mean and Change From Baseline (Day 1 Pre-dose) in mLCVA and mHCVA at Days 3, 8, and 15 and Week 6 Day 3, Change from Baseline in mHCVA	1.26 Letters Read Standard Deviation 0.467	3.00 Letters Read Standard Deviation 0.471
Mean and Change From Baseline (Day 1 Pre-dose) in mLCVA and mHCVA at Days 3, 8, and 15 and Week 6 Day 8, Change from Baseline in mHCVA	1.32 Letters Read Standard Deviation 0.507	3.83 Letters Read Standard Deviation 0.508
Mean and Change From Baseline (Day 1 Pre-dose) in mLCVA and mHCVA at Days 3, 8, and 15 and Week 6 Day 15, Change from Baseline in mHCVA	2.06 Letters Read Standard Deviation 0.481	4.13 Letters Read Standard Deviation 0.483
Mean and Change From Baseline (Day 1 Pre-dose) in mLCVA and mHCVA at Days 3, 8, and 15 and Week 6 Week 6, Change from Baseline in mHCVA	2.24 Letters Read Standard Deviation 0.514	3.36 Letters Read Standard Deviation 0.517
Mean and Change From Baseline (Day 1 Pre-dose) in mLCVA and mHCVA at Days 3, 8, and 15 and Week 6 Day 3, Change from Baseline in mLCVA	7.48 Letters Read Standard Deviation 0.551	10.66 Letters Read Standard Deviation 0.554
Mean and Change From Baseline (Day 1 Pre-dose) in mLCVA and mHCVA at Days 3, 8, and 15 and Week 6 Day 8, Change from Baseline in mLCVA	6.86 Letters Read Standard Deviation 0.545	10.71 Letters Read Standard Deviation 0.545
Mean and Change From Baseline (Day 1 Pre-dose) in mLCVA and mHCVA at Days 3, 8, and 15 and Week 6 Day 15, Change from Baseline in mLCVA	7.67 Letters Read Standard Deviation 0.582	10.01 Letters Read Standard Deviation 0.582

SECONDARY outcome

Timeframe: 6 Weeks

Population: The number of subjects whose data is analyzed for a particular outcome depends on how many subjects had an assessment at each particular timepoint of interest.

This outcome measure will investigate the mean and change from baseline in PD at Days 3, 8, and 15 and Week 6.

Outcome measures

Outcome measures
Measure	Phentolamine Ophthalmic Solution Vehicle n=99 Participants Drug: Placebo, Placebo: Once daily dosing	0.75% Phentolamine Ophthalmic Solution n=98 Participants 0.75% phentolamine ophthalmic solution: Daily dosing
Mean and Change From Baseline (Day 1 Pre-dose) in PD at Days 3, 8, and 15 and Week 6 Day 15	-0.175 millimeters Standard Deviation 0.0663	-1.232 millimeters Standard Deviation 0.0666
Mean and Change From Baseline (Day 1 Pre-dose) in PD at Days 3, 8, and 15 and Week 6 Week 6	-0.202 millimeters Standard Deviation 0.0645	-1.151 millimeters Standard Deviation 0.0648
Mean and Change From Baseline (Day 1 Pre-dose) in PD at Days 3, 8, and 15 and Week 6 Day 3	-0.199 millimeters Standard Deviation 0.0626	-1.359 millimeters Standard Deviation 0.0630
Mean and Change From Baseline (Day 1 Pre-dose) in PD at Days 3, 8, and 15 and Week 6 Day 8	-0.198 millimeters Standard Deviation 0.0648	-1.380 millimeters Standard Deviation 0.0652

SECONDARY outcome

Timeframe: 6 Weeks

Population: The number of subjects whose data is analyzed for a particular outcome depends on how many subjects had an assessment at each particular timepoint of interest.

This outcome measure will investigate the change in subject questionnaire responses compared to baseline at Days 3, 8, and 15 and Week 6. The Vision and Night Driving Questionnaire (VND-Q) is comprised of 9 questions related to visual difficulties when driving at night. Subjects were asked to assess, on a 1 (no difficulty) to 5 (extreme difficulty) scale, how much difficulty they had or would have with certain tasks while wearing their normal glasses or contact lenses (if any) for night driving.

Outcome measures

Outcome measures
Measure	Phentolamine Ophthalmic Solution Vehicle n=100 Participants Drug: Placebo, Placebo: Once daily dosing	0.75% Phentolamine Ophthalmic Solution n=99 Participants 0.75% phentolamine ophthalmic solution: Daily dosing
Change in Subject Questionnaire Responses Compared to Baseline (Day 1 Pre-dose) at Days 3, 8, and 15 and Week 6 Day 3	-0.10 Units on a Scale Standard Deviation 0.082	-0.24 Units on a Scale Standard Deviation 0.082
Change in Subject Questionnaire Responses Compared to Baseline (Day 1 Pre-dose) at Days 3, 8, and 15 and Week 6 Day 8	-0.14 Units on a Scale Standard Deviation 0.096	-0.61 Units on a Scale Standard Deviation 0.096
Change in Subject Questionnaire Responses Compared to Baseline (Day 1 Pre-dose) at Days 3, 8, and 15 and Week 6 Day 15	-0.40 Units on a Scale Standard Deviation 0.110	-0.97 Units on a Scale Standard Deviation 0.110
Change in Subject Questionnaire Responses Compared to Baseline (Day 1 Pre-dose) at Days 3, 8, and 15 and Week 6 Week 6	-0.68 Units on a Scale Standard Deviation 0.134	-1.34 Units on a Scale Standard Deviation 0.135

Adverse Events

Phentolamine Ophthalmic Solution Vehicle

Serious events: 3 serious events

Other events: 27 other events

Deaths: 0 deaths

0.75% Phentolamine Ophthalmic Solution

Serious events: 1 serious events

Other events: 60 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phentolamine Ophthalmic Solution Vehicle n=100 participants at risk Drug: Placebo, Placebo: Once daily dosing	0.75% Phentolamine Ophthalmic Solution n=99 participants at risk 0.75% phentolamine ophthalmic solution: Daily dosing
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Retinal detachment	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Injury, poisoning and procedural complications Multiple fractures	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Metabolism and nutrition disorders Dehyrdration	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.

Other adverse events

Other adverse events
Measure	Phentolamine Ophthalmic Solution Vehicle n=100 participants at risk Drug: Placebo, Placebo: Once daily dosing	0.75% Phentolamine Ophthalmic Solution n=99 participants at risk 0.75% phentolamine ophthalmic solution: Daily dosing
Eye disorders Visual acuity reduced	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	2.0% 2/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Chalazion	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	2.0% 2/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Conjunctivitis	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	2.0% 2/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Conjunctivitis bacterial	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	2.0% 2/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Conjunctival hyperaemia	5.0% 5/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	35.4% 35/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Punctate keratitis	3.0% 3/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	3.0% 3/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Eczema eyelids	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	5.1% 5/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Conjunctivitis allergic	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	3.0% 3/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Foreign body sensation in eyes	3.0% 3/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Vision blurred	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	2.0% 2/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Dry eye	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Eye irritation	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Eye pain	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	2.0% 2/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Eye pruritus	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	2.0% 2/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Hordeolum	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	2.0% 2/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Noninfective conjunctivitis	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	2.0% 2/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Swelling of eyelid	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	2.0% 2/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Blepharitis	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Cataract	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Cataract nuclear	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Conjunctival hemorrhage	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Conjunctivitis viral	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Eye inflammation	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Eyelid oedema	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Eyelids pruritus	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Lacrimation increased	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Myopia	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Ocular hyperaemia	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Photophobia	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Retinal detachment	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Traumatic iritis	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Eye disorders Vitreous detachment	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
General disorders Instillation site irritation	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	19.2% 19/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
General disorders Instillation site erythema	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	4.0% 4/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
General disorders Hot flush	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
General disorders Instillation site lacrimation	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Nervous system disorders Dysgeusia	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	11.1% 11/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Nervous system disorders Dizziness	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Nervous system disorders Headache	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Nervous system disorders Tension headache	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Infections and infestations Influenza	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	2.0% 2/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Infections and infestations Upper respiratory tract infection	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	2.0% 2/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Infections and infestations Urinary tract infection	2.0% 2/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Infections and infestations Ear infection	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Infections and infestations Sinusitis	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Injury, poisoning and procedural complications Animal bite	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Injury, poisoning and procedural complications Burns second degree	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Injury, poisoning and procedural complications Multiple fractures	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Injury, poisoning and procedural complications Muscle strain	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Injury, poisoning and procedural complications Procedural pain	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Injury, poisoning and procedural complications Thermal burn	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Endocrine disorders Hypothyroidism	2.0% 2/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Endocrine disorders Hyperthyroidism	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Immune system disorders Drug hypersensitivity	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Psychiatric disorders Anxiety	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Psychiatric disorders Insomnia	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Reproductive system and breast disorders Mastoptosis	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Skin and subcutaneous tissue disorders Rash	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Vascular disorders Hypertension	3.0% 3/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	1.0% 1/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Gastrointestinal disorders Dry mouth	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Gastrointestinal disorders Gastrointestinal bacterial overgrowth	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Surgical and medical procedures Postoperative care	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.
Surgical and medical procedures Rehabilitation therapy	1.0% 1/100 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.	0.00% 0/99 • from enrollment until end of study, up to 48 weeks All adverse events, including ocular and non-ocular adverse events, were summarized and analyzed at the participant level. The number at risk and number affected reflect study participants rather than eyes. Separate ocular and systemic Arms/Groups were therefore not created because the same participant populations were used for all adverse event analyses.

Additional Information

Study Director

Opus Genetics

Phone: 984-884-6030

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60