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Trial Outcomes & Findings for Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia (NCT NCT06542497)

NCT ID: NCT06542497

Last Updated: 2026-08-17

Results Overview

The primary efficacy endpoint is the percentage of participants with ≥ 15 letters of improvement in binocular DCNVA and with \< 5 letters of loss in binocular BCDVA from baseline comparing POS-treated participants to placebo-treated participants at 12 hours post-dose at Visit 4 (Day 8).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

569 participants

Primary outcome timeframe

8 Days

Results posted on

2026-08-17

Participant Flow

Participant milestones

Participant milestones
Measure
0.75% Phentolamine Ophthalmic Solution
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist 0.75% phentolamine ophthalmic solution: Once daily dosing
Phentolamine Ophthalmic Solution Vehicle
Drug: Placebo Placebo: Once daily dosing
Overall Study
STARTED
341
228
Overall Study
COMPLETED
233
195
Overall Study
NOT COMPLETED
108
33

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
0.75% Phentolamine Ophthalmic Solution
n=341 Participants
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
n=228 Participants
phentolamine ophthalmic solution vehicle, Drug: Placebo
Total
n=569 Participants
Total of all reporting groups
Age, Continuous
54.3 Years
STANDARD_DEVIATION 5.08 • n=51 Participants
54.5 Years
STANDARD_DEVIATION 4.91 • n=51 Participants
54.4 Years
STANDARD_DEVIATION 5.01 • n=102 Participants
Sex: Female, Male
Female
229 Participants
n=51 Participants
148 Participants
n=51 Participants
377 Participants
n=102 Participants
Sex: Female, Male
Male
112 Participants
n=51 Participants
80 Participants
n=51 Participants
192 Participants
n=102 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
48 Participants
n=51 Participants
34 Participants
n=51 Participants
82 Participants
n=102 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
293 Participants
n=51 Participants
194 Participants
n=51 Participants
487 Participants
n=102 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=51 Participants
0 Participants
n=51 Participants
0 Participants
n=102 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
n=51 Participants
1 Participants
n=51 Participants
3 Participants
n=102 Participants
Race (NIH/OMB)
Asian
14 Participants
n=51 Participants
8 Participants
n=51 Participants
22 Participants
n=102 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=51 Participants
0 Participants
n=51 Participants
1 Participants
n=102 Participants
Race (NIH/OMB)
Black or African American
42 Participants
n=51 Participants
27 Participants
n=51 Participants
69 Participants
n=102 Participants
Race (NIH/OMB)
White
276 Participants
n=51 Participants
191 Participants
n=51 Participants
467 Participants
n=102 Participants
Race (NIH/OMB)
More than one race
6 Participants
n=51 Participants
1 Participants
n=51 Participants
7 Participants
n=102 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=51 Participants
0 Participants
n=51 Participants
0 Participants
n=102 Participants
BCDVA in the Study Eye
57.9 Letters
STANDARD_DEVIATION 3.01 • n=51 Participants
58.1 Letters
STANDARD_DEVIATION 3.36 • n=51 Participants
58 Letters
STANDARD_DEVIATION 3.15 • n=102 Participants
BCDVA Binocular
59.4 Letters
STANDARD_DEVIATION 3.29 • n=51 Participants
59.7 Letters
STANDARD_DEVIATION 3.74 • n=51 Participants
59.5 Letters
STANDARD_DEVIATION 3.48 • n=102 Participants
DCNVA Binocular
47.2 Letters
STANDARD_DEVIATION 3.51 • n=51 Participants
46.9 Letters
STANDARD_DEVIATION 3.96 • n=51 Participants
47.1 Letters
STANDARD_DEVIATION 3.70 • n=102 Participants
DCNVA in the Study Eye
43.1 Letters
STANDARD_DEVIATION 4.31 • n=51 Participants
43.7 Letters
STANDARD_DEVIATION 4.41 • n=51 Participants
43.4 Letters
STANDARD_DEVIATION 4.36 • n=102 Participants
Irides Type
Light
151 Participants
n=51 Participants
102 Participants
n=51 Participants
253 Participants
n=102 Participants
Irides Type
Dark
190 Participants
n=51 Participants
126 Participants
n=51 Participants
316 Participants
n=102 Participants
Study Eye
OD
223 Participants
n=51 Participants
158 Participants
n=51 Participants
381 Participants
n=102 Participants
Study Eye
OS
118 Participants
n=51 Participants
70 Participants
n=51 Participants
188 Participants
n=102 Participants
BCDVA in the Fellow Eye
57.5 Letters
STANDARD_DEVIATION 2.77 • n=51 Participants
58.1 Letters
STANDARD_DEVIATION 3.29 • n=51 Participants
57.8 Letters
STANDARD_DEVIATION 3.00 • n=102 Participants
DCNVA in the Fellow Eye
45.7 Letters
STANDARD_DEVIATION 4.08 • n=51 Participants
45.9 Letters
STANDARD_DEVIATION 4.11 • n=51 Participants
45.8 Letters
STANDARD_DEVIATION 4.09 • n=102 Participants
DCIVA in the Study Eye
47.0 Letters
STANDARD_DEVIATION 5.70 • n=51 Participants
47.1 Letters
STANDARD_DEVIATION 5.94 • n=51 Participants
47.0 Letters
STANDARD_DEVIATION 5.79 • n=102 Participants
DCIVA in the Fellow Eye
49.0 Letters
STANDARD_DEVIATION 5.84 • n=51 Participants
48.4 Letters
STANDARD_DEVIATION 6.19 • n=51 Participants
48.7 Letters
STANDARD_DEVIATION 5.98 • n=102 Participants
DCIVA Binocular
51.2 Letters
STANDARD_DEVIATION 5.40 • n=51 Participants
50.9 Letters
STANDARD_DEVIATION 5.71 • n=51 Participants
51.1 Letters
STANDARD_DEVIATION 5.52 • n=102 Participants
PD in Study Eye
4.737 millimeters
STANDARD_DEVIATION 0.675 • n=51 Participants
4.758 millimeters
STANDARD_DEVIATION 0.701 • n=51 Participants
4.746 millimeters
STANDARD_DEVIATION 0.685 • n=102 Participants
PD in Fellow Eye
4.778 millimeters
STANDARD_DEVIATION 0.723 • n=51 Participants
4.787 millimeters
STANDARD_DEVIATION 0.677 • n=51 Participants
4.782 millimeters
STANDARD_DEVIATION 0.705 • n=102 Participants
IOP in the Study Eye
15.1 mmHg
STANDARD_DEVIATION 2.64 • n=51 Participants
14.6 mmHg
STANDARD_DEVIATION 2.59 • n=51 Participants
14.9 mmHg
STANDARD_DEVIATION 2.63 • n=102 Participants
IOP in the Fellow Eye
15.1 mmHg
STANDARD_DEVIATION 2.59 • n=51 Participants
14.6 mmHg
STANDARD_DEVIATION 2.58 • n=51 Participants
14.9 mmHg
STANDARD_DEVIATION 2.59 • n=102 Participants

PRIMARY outcome

Timeframe: 8 Days

The primary efficacy endpoint is the percentage of participants with ≥ 15 letters of improvement in binocular DCNVA and with \< 5 letters of loss in binocular BCDVA from baseline comparing POS-treated participants to placebo-treated participants at 12 hours post-dose at Visit 4 (Day 8).

Outcome measures

Outcome measures
Measure
0.75% Phentolamine Ophthalmic Solution
n=338 Participants
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
n=226 Participants
phentolamine ophthalmic solution vehicle, Drug: Placebo
Percentage of Subjects With ≥ 15 Letters of Improvement in Binocular DCNVA and With < 5 Letters of Loss in Binocular BCDVA From Baseline Comparing POS-treated Participants to Placebo-treated Participants at 12 Hours Post-dose at Visit 4 (Day 8)
92 Participants
26 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 secondary efficacy endpoint is the percentage of participants with ≥ 15 letters of improvement in binocular DCNVA and with \< 5 letters of loss in binocular BCDVA from baseline comparing POS-treated participants to placebo-treated participants at 12 hours post-dose at Day 1 (1-hour post-dose), Day 3, and Week 6.

Outcome measures

Outcome measures
Measure
0.75% Phentolamine Ophthalmic Solution
n=341 Participants
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
n=228 Participants
phentolamine ophthalmic solution vehicle, Drug: Placebo
Percentage of Subjects With ≥ 15 Letters of Improvement in Binocular DCNVA and With < 5 Letters of Loss in Binocular BCDVA From Baseline at Day 1 (1-hour Post-dose), Day 3, and Week 6
Day 1, 1 hour post-dose
70 Participants
14 Participants
Percentage of Subjects With ≥ 15 Letters of Improvement in Binocular DCNVA and With < 5 Letters of Loss in Binocular BCDVA From Baseline at Day 1 (1-hour Post-dose), Day 3, and Week 6
Day 3
78 Participants
24 Participants
Percentage of Subjects With ≥ 15 Letters of Improvement in Binocular DCNVA and With < 5 Letters of Loss in Binocular BCDVA From Baseline at Day 1 (1-hour Post-dose), Day 3, and Week 6
Week 6
82 Participants
31 Participants
Percentage of Subjects With ≥ 15 Letters of Improvement in Binocular DCNVA and With < 5 Letters of Loss in Binocular BCDVA From Baseline at Day 1 (1-hour Post-dose), Day 3, and Week 6
Day 8
92 Participants
26 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.

The percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular and Binocular) at Day 1 (0.5 hours and 1 hour post-dose), Day 3, Day 8, and Week 6.

Outcome measures

Outcome measures
Measure
0.75% Phentolamine Ophthalmic Solution
n=341 Participants
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
n=228 Participants
phentolamine ophthalmic solution vehicle, Drug: Placebo
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1 Hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 0.5 hours post-dose: ≥ 15 letters
40 Participants
13 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1 Hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1 hour post-dose: ≥ 15 letters
71 Participants
15 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1 Hour Post-dose), Day 3, Day 8, and Week 6
Day 3: ≥ 15 letters
79 Participants
25 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1 Hour Post-dose), Day 3, Day 8, and Week 6
Day 8: ≥ 15 letters
92 Participants
27 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1 Hour Post-dose), Day 3, Day 8, and Week 6
Week 6: ≥ 15 letters
83 Participants
32 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1 Hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 0.5 hours post-dose: ≥ 10 letters
99 Participants
51 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1 Hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: ≥ 10 letters
164 Participants
66 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1 Hour Post-dose), Day 3, Day 8, and Week 6
Day 3: ≥ 10 letters
166 Participants
63 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1 Hour Post-dose), Day 3, Day 8, and Week 6
Day 8: ≥ 10 letters
187 Participants
66 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1 Hour Post-dose), Day 3, Day 8, and Week 6
Week 6: ≥ 10 letters
163 Participants
77 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1 Hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 0.5 hours post-dose: ≥ 5 letters
214 Participants
111 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1 Hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: ≥ 5 letters
257 Participants
136 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1 Hour Post-dose), Day 3, Day 8, and Week 6
Day 3: ≥ 5 letters
272 Participants
134 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1 Hour Post-dose), Day 3, Day 8, and Week 6
Day 8: ≥ 5 letters
280 Participants
142 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1 Hour Post-dose), Day 3, Day 8, and Week 6
Week 6: ≥ 5 letters
236 Participants
142 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 ≥ 5, ≥ 10, and ≥ 15 letters of improvement in DCNVA from baseline (monocular - study eye) at Day 1 (0.5 hours and 1-hour post-dose), Day 3, Day 8, and Week 6.

Outcome measures

Outcome measures
Measure
0.75% Phentolamine Ophthalmic Solution
n=341 Participants
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
n=228 Participants
phentolamine ophthalmic solution vehicle, Drug: Placebo
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 0.5 hours post-dose: ≥ 15 letters
40 Participants
10 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: ≥ 15 letters
62 Participants
21 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: ≥ 15 letters
61 Participants
12 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: ≥ 15 letters
78 Participants
23 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: ≥ 15 letters
66 Participants
23 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 0.5 hours post-dose: ≥ 10 letters
96 Participants
38 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: ≥ 10 letters
150 Participants
57 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: ≥ 10 letters
152 Participants
54 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: ≥ 10 letters
146 Participants
53 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: ≥ 10 letters
133 Participants
58 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 0.5 hours post-dose: ≥ 5 letters
207 Participants
105 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: ≥ 5 letters
260 Participants
130 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: ≥ 5 letters
247 Participants
119 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: ≥ 5 letters
252 Participants
123 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: ≥ 5 letters
219 Participants
120 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 change in DCNVA from baseline (binocular) at Day 1 (0.5 hours and 1-hour post-dose), Day 3, Day 8, and Week 6.

Outcome measures

Outcome measures
Measure
0.75% Phentolamine Ophthalmic Solution
n=341 Participants
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
n=228 Participants
phentolamine ophthalmic solution vehicle, Drug: Placebo
Change in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8
10.10 Letters Read
Standard Error 0.35
6.10 Letters Read
Standard Error 0.42
Change in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 0.5 hours post-dose
6.58 Letters Read
Standard Error 0.32
4.50 Letters Read
Standard Error 0.40
Change in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1 hour post-dose
8.96 Letters Read
Standard Error 0.34
5.66 Letters Read
Standard Error 0.41
Change in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3
9.38 Letters Read
Standard Error 0.34
5.68 Letters Read
Standard Error 0.42
Change in DCNVA From Baseline (Binocular) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6
10.48 Letters Read
Standard Error 0.37
6.67 Letters Read
Standard Error 0.43

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 DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 hours and 1-hour post-dose), Day 3, Day 8, and Week 6

Outcome measures

Outcome measures
Measure
0.75% Phentolamine Ophthalmic Solution
n=341 Participants
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
n=228 Participants
phentolamine ophthalmic solution vehicle, Drug: Placebo
Change in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6
9.29 Letters Read
Standard Deviation 0.39
5.54 Letters Read
Standard Deviation 0.46
Change in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 0.5 Hours Post-dose
6.53 Letters Read
Standard Deviation 0.33
4.59 Letters Read
Standard Deviation 0.41
Change in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-Hour Post-dose
8.68 Letters Read
Standard Deviation 0.34
5.63 Letters Read
Standard Deviation 0.42
Change in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3
8.62 Letters Read
Standard Deviation 0.36
4.80 Letters Read
Standard Deviation 0.44
Change in DCNVA From Baseline (Monocular - Study Eye) at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8
9.01 Letters Read
Standard Deviation 0.36
5.22 Letters Read
Standard Deviation 0.44

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 investigates the change in mean binocular DCNVA from baseline at Week 6 compared to the best prior observed change from baseline in mean binocular DCNVA in subjects treated with POS.

Outcome measures

Outcome measures
Measure
0.75% Phentolamine Ophthalmic Solution
n=341 Participants
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
phentolamine ophthalmic solution vehicle, Drug: Placebo
Change in Mean Binocular DCNVA From Baseline at Week 6 Compared to the Best Prior Observed Change From Baseline in Mean Binocular DCNVA in Subjects Treated With POS
Day 1, 0.5 hours post-dose
6.6 Letters Read
Standard Error 0.34
—
Change in Mean Binocular DCNVA From Baseline at Week 6 Compared to the Best Prior Observed Change From Baseline in Mean Binocular DCNVA in Subjects Treated With POS
Day 1, 1 hour post-dose
9.0 Letters Read
Standard Error 0.36
—
Change in Mean Binocular DCNVA From Baseline at Week 6 Compared to the Best Prior Observed Change From Baseline in Mean Binocular DCNVA in Subjects Treated With POS
Day 3
9.3 Letters Read
Standard Error 0.35
—
Change in Mean Binocular DCNVA From Baseline at Week 6 Compared to the Best Prior Observed Change From Baseline in Mean Binocular DCNVA in Subjects Treated With POS
Day 8
10.0 Letters Read
Standard Error 0.36
—
Change in Mean Binocular DCNVA From Baseline at Week 6 Compared to the Best Prior Observed Change From Baseline in Mean Binocular DCNVA in Subjects Treated With POS
Week 6
10.4 Letters Read
Standard Error 0.36
—

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 DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 hours and 1-hour post-dose), Day 3, Day 8, and Week 6.

Outcome measures

Outcome measures
Measure
0.75% Phentolamine Ophthalmic Solution
n=341 Participants
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
n=228 Participants
phentolamine ophthalmic solution vehicle, Drug: Placebo
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3
2 Participants
0 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 0.5 hours post-dose: ≤ 20/15
3 Participants
0 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1 hour post-dose: ≤ 20/15
3 Participants
0 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8
3 Participants
0 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6
2 Participants
0 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 0.5 hours post-dose: ≤ 20/20
9 Participants
2 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: ≤ 20/20
11 Participants
1 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: ≤ 20/20
10 Participants
2 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: ≤ 20/20
15 Participants
0 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: ≤ 20/20
11 Participants
5 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 0.5 hours post-dose: ≤ 20/25
27 Participants
8 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: ≤ 20/25
48 Participants
10 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: ≤ 20/25
48 Participants
19 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: ≤ 20/25
59 Participants
20 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: ≤ 20/25
50 Participants
23 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 0.5 hours post-dose: ≤ 20/32
73 Participants
34 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: ≤ 20/32
123 Participants
39 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: ≤ 20/32
132 Participants
43 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: ≤ 20/32
147 Participants
49 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: ≤ 20/32
125 Participants
57 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 0.5 hours post-dose: ≤ 20/40
166 Participants
68 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: ≤ 20/40
211 Participants
91 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: ≤ 20/40
206 Participants
95 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: ≤ 20/40
228 Participants
99 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: ≤ 20/40
203 Participants
105 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 0.5 hours post-dose: ≤ 20/50
261 Participants
155 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: ≤ 20/50
284 Participants
164 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: ≤ 20/50
292 Participants
165 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: ≤ 20/50
299 Participants
166 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: ≤ 20/50
261 Participants
165 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 0.5 hours post-dose: ≤ 20/63
316 Participants
203 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: ≤ 20/63
324 Participants
209 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: ≤ 20/63
327 Participants
207 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: ≤ 20/63
326 Participants
207 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: ≤ 20/63
280 Participants
197 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 0.5 hours post-dose: ≤ 20/80
338 Participants
224 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: ≤ 20/80
338 Participants
225 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: ≤ 20/80
336 Participants
222 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: ≤ 20/80
337 Participants
222 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: ≤ 20/80
283 Participants
211 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 0.5 hours post-dose: ≤ 20/100
339 Participants
228 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: ≤ 20/100
340 Participants
228 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: ≤ 20/100
337 Participants
225 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: ≤ 20/100
338 Participants
225 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: ≤ 20/100
283 Participants
213 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 0.5 hours post-dose: ≤ 20/125
340 Participants
228 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: ≤ 20/125
340 Participants
228 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: ≤ 20/125
337 Participants
225 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: ≤ 20/125
338 Participants
226 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: ≤ 20/125
283 Participants
215 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 0.5 hours post-dose: ≤ 20/160
340 Participants
228 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: ≤ 20/160
340 Participants
228 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: ≤ 20/160
337 Participants
225 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: ≤ 20/160
338 Participants
226 Participants
Percentage of Subjects With DCNVA ≤ 20/15, ≤ 20/20, ≤ 20/25, ≤ 20/32, ≤ 20/40, ≤ 20/50, ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: ≤ 20/160
283 Participants
215 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 baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 with a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 hours and 1-hour post-dose), Day 3, Day 8, and Week 6.

Outcome measures

Outcome measures
Measure
0.75% Phentolamine Ophthalmic Solution
n=341 Participants
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
n=228 Participants
phentolamine ophthalmic solution vehicle, Drug: Placebo
Percentage of Subjects With Baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 With a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8, ≤ 20/63 & ≥ 15 letters · ≥ 15 letters
67 Participants
21 Participants
Percentage of Subjects With Baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 With a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8, ≤ 20/80 & ≥ 15 letters · ≥ 15 letters
86 Participants
26 Participants
Percentage of Subjects With Baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 With a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8, ≤ 20/100 & ≥ 15 letters · ≥ 15 letters
92 Participants
27 Participants
Percentage of Subjects With Baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 With a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8, ≤ 20/125 & ≥ 15 letters · ≥ 15 letters
92 Participants
27 Participants
Percentage of Subjects With Baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 With a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8, ≤ 20/160 & ≥ 15 letters · ≥ 15 letters
92 Participants
27 Participants
Percentage of Subjects With Baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 With a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8, ≤ 20/63 & ≥ 10 letters · ≥ 15 letters
150 Participants
53 Participants
Percentage of Subjects With Baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 With a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8, ≤ 20/80 & ≥ 10 letters · ≥ 15 letters
181 Participants
65 Participants
Percentage of Subjects With Baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 With a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8, ≤ 20/100 & ≥ 10 letters · ≥ 15 letters
187 Participants
66 Participants
Percentage of Subjects With Baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 With a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8, ≤ 20/125 & ≥ 10 letters · ≥ 15 letters
187 Participants
66 Participants
Percentage of Subjects With Baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 With a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8, ≤ 20/160 & ≥ 10 letters · ≥ 15 letters
187 Participants
66 Participants
Percentage of Subjects With Baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 With a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8, ≤ 20/63 & ≥ 5 letters · ≥ 15 letters
230 Participants
107 Participants
Percentage of Subjects With Baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 With a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8, ≤ 20/80 & ≥ 5 letters · ≥ 15 letters
271 Participants
136 Participants
Percentage of Subjects With Baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 With a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8, ≤ 20/100 & ≥ 5 letters · ≥ 15 letters
280 Participants
142 Participants
Percentage of Subjects With Baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 With a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8, ≤ 20/125 & ≥ 5 letters · ≥ 15 letters
280 Participants
142 Participants
Percentage of Subjects With Baseline DCNVA ≤ 20/63, ≤ 20/80, ≤ 20/100, ≤ 20/125, and ≤ 20/160 With a ≥ 10-Letter and ≥ 15-Letter Improvement in DCNVA at Day 1 (0.5 Hours and 1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8, ≤ 20/160 & ≥ 5 letters · ≥ 15 letters
280 Participants
142 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 ≥ 5, ≥ 10, and ≥ 15 letters of improvement in binocular DCIVA from baseline at Day 1 (1-hour post-dose), Day 3, Day 8, and Week 6.

Outcome measures

Outcome measures
Measure
0.75% Phentolamine Ophthalmic Solution
n=341 Participants
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
n=228 Participants
phentolamine ophthalmic solution vehicle, Drug: Placebo
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose, ≥ 15 letters · ≥ 15 letters
16 Participants
4 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: ≥ 15 letters · ≥ 15 letters
22 Participants
3 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: ≥ 15 letters · ≥ 15 letters
27 Participants
12 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: ≥ 15 letters · ≥ 15 letters
27 Participants
19 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose, ≥ 10 letters · ≥ 15 letters
66 Participants
23 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: ≥ 10 letters · ≥ 15 letters
90 Participants
36 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: ≥ 10 letters · ≥ 15 letters
105 Participants
42 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: ≥ 10 letters · ≥ 15 letters
84 Participants
40 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: ≥ 5 letters · ≥ 15 letters
193 Participants
92 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: ≥ 5 letters · ≥ 15 letters
206 Participants
97 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: ≥ 5 letters · ≥ 15 letters
217 Participants
108 Participants
Percentage of Subjects With ≥ 5, ≥ 10, and ≥ 15 Letters of Improvement in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: ≥ 5 letters · ≥ 15 letters
189 Participants
99 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 change in binocular DCIVA from baseline at Day 1 (1-hour post-dose), Day 3, Day 8, and Week 6.

Outcome measures

Outcome measures
Measure
0.75% Phentolamine Ophthalmic Solution
n=341 Participants
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
n=228 Participants
phentolamine ophthalmic solution vehicle, Drug: Placebo
Change in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1 hour post-dose
4.89 Letters Read
Standard Error 0.26
3.18 Letters Read
Standard Error 0.31
Change in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3
5.84 Letters Read
Standard Error 0.27
3.40 Letters Read
Standard Error 0.33
Change in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8
6.40 Letters Read
Standard Error 0.27
3.98 Letters Read
Standard Error 0.33
Change in Binocular DCIVA From Baseline at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6
6.43 Letters Read
Standard Error 0.28
4.01 Letters Read
Standard Error 0.34

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 loss or improvement in BCDVA from baseline (Binocular) at Day 1 (1-hour post-dose), Day 3, Day 8, and Week 6.

Outcome measures

Outcome measures
Measure
0.75% Phentolamine Ophthalmic Solution
n=341 Participants
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
n=228 Participants
phentolamine ophthalmic solution vehicle, Drug: Placebo
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: >= 15 Letters
0 Participants
0 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: >= 15 Letters
0 Participants
0 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: >= 15 Letters
0 Participants
0 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: >= 15 Letters
0 Participants
0 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: >= 10 Letters
1 Participants
1 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: >= 10 Letters
2 Participants
2 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: >= 10 Letters
3 Participants
3 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: >= 10 Letters
6 Participants
4 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: >= 5 Letters
28 Participants
14 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: >= 5 Letters
55 Participants
28 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: >= 5 Letters
79 Participants
41 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: >= 5 Letters
64 Participants
37 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: >= -4 to <= 4 Letters
296 Participants
200 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: >= -4 to <= 4 Letters
271 Participants
185 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: >= -4 to <= 4 Letters
252 Participants
180 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: >= -4 to <= 4 Letters
251 Participants
170 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: <= -5 Letters
16 Participants
14 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: <= -5 Letters
11 Participants
12 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: <= -5 Letters
7 Participants
5 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: <= -5 Letters
10 Participants
11 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: <= -10 Letters
2 Participants
1 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: <= -10 Letters
1 Participants
0 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: <= -10 Letters
0 Participants
0 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: <= -10 Letters
1 Participants
0 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1-hour post-dose: <= -15 Letters
0 Participants
0 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3: <= -15 Letters
1 Participants
0 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8: <= -15 Letters
0 Participants
0 Participants
Percentage of Subjects With Loss or Improvement in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6: <= -15 Letters
1 Participants
0 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 change in BCDVA from baseline (Binocular) at Day 1 (1-hour post-dose), Day 3, Day 8, and Week 6.

Outcome measures

Outcome measures
Measure
0.75% Phentolamine Ophthalmic Solution
n=341 Participants
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
n=228 Participants
phentolamine ophthalmic solution vehicle, Drug: Placebo
Change in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8
1.44 Letters Read
Standard Deviation 0.18
1.30 Letters Read
Standard Deviation 0.2
Change in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6
1.02 Letters Read
Standard Deviation 0.20
0.83 Letters Read
Standard Deviation 0.25
Change in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1 hour post-dose
0.49 Letters Read
Standard Deviation 0.17
0.13 Letters Read
Standard Deviation 0.20
Change in BCDVA From Baseline (Binocular) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3
0.86 Letters Read
Standard Deviation 0.19
0.64 Letters Read
Standard Deviation 0.23

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 BCDVA From Baseline (Monocular - Study Eye) at Day 1 (1-hour post-dose), Day 3, Day 8, and Week 6.

Outcome measures

Outcome measures
Measure
0.75% Phentolamine Ophthalmic Solution
n=341 Participants
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
n=228 Participants
phentolamine ophthalmic solution vehicle, Drug: Placebo
Change in BCDVA From Baseline (Monocular - Study Eye) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 1, 1 Hour Post-dose
0.49 Letters Read
Standard Deviation 0.17
0.13 Letters Read
Standard Deviation 0.20
Change in BCDVA From Baseline (Monocular - Study Eye) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 3
0.86 Letters Read
Standard Deviation 0.19
0.64 Letters Read
Standard Deviation 0.23
Change in BCDVA From Baseline (Monocular - Study Eye) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Day 8
1.44 Letters Read
Standard Deviation 0.18
1.30 Letters Read
Standard Deviation 0.22
Change in BCDVA From Baseline (Monocular - Study Eye) at Day 1 (1-hour Post-dose), Day 3, Day 8, and Week 6
Week 6
1.02 Letters Read
Standard Deviation 0.20
0.83 Letters Read
Standard Deviation 0.25

SECONDARY outcome

Timeframe: 8 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 change in pupil diameter from baseline at Day 3 and Day 8.

Outcome measures

Outcome measures
Measure
0.75% Phentolamine Ophthalmic Solution
n=341 Participants
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
n=228 Participants
phentolamine ophthalmic solution vehicle, Drug: Placebo
Change in Pupil Diameter From Baseline at Day 3 and Day 8
Day 3
-1.17 millimeters
Standard Deviation 0.03
-0.16 millimeters
Standard Deviation 0.04
Change in Pupil Diameter From Baseline at Day 3 and Day 8
Day 8
-1.17 millimeters
Standard Deviation 0.03
-0.21 millimeters
Standard Deviation 0.04

SECONDARY outcome

Timeframe: 8 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 Change in Pupil Diameter from Baseline at Day 3 \& Day 8.

Outcome measures

Outcome measures
Measure
0.75% Phentolamine Ophthalmic Solution
n=341 Participants
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
n=228 Participants
phentolamine ophthalmic solution vehicle, Drug: Placebo
Percent Change in Pupil Diameter From Baseline at Day 3 & Day 8
Day 3
-24.51 Percent Change
Standard Deviation 0.67
-2.93 Percent Change
Standard Deviation 0.82
Percent Change in Pupil Diameter From Baseline at Day 3 & Day 8
Day 8
-24.48 Percent Change
Standard Deviation 0.66
-4.14 Percent Change
Standard Deviation 0.81

SECONDARY outcome

Timeframe: 8 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 percentage of subjects with pupil diameter of \< 3.5, \< 3.0, \< 2.5, \< 2.0, and \< 1.5 mm at Day 3 and Day 8.

Outcome measures

Outcome measures
Measure
0.75% Phentolamine Ophthalmic Solution
n=341 Participants
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
n=228 Participants
phentolamine ophthalmic solution vehicle, Drug: Placebo
Percentage of Subjects With Pupil Diameter of < 3.5, < 3.0, < 2.5, < 2.0, and < 1.5 mm at Day 3 and Day 8
Day 3: < 3.0 mm
86 Participants
2 Participants
Percentage of Subjects With Pupil Diameter of < 3.5, < 3.0, < 2.5, < 2.0, and < 1.5 mm at Day 3 and Day 8
Day 8: < 3.0 mm
78 Participants
5 Participants
Percentage of Subjects With Pupil Diameter of < 3.5, < 3.0, < 2.5, < 2.0, and < 1.5 mm at Day 3 and Day 8
Day 3: < 2.5 mm
16 Participants
0 Participants
Percentage of Subjects With Pupil Diameter of < 3.5, < 3.0, < 2.5, < 2.0, and < 1.5 mm at Day 3 and Day 8
Day 8: < 2.5 mm
10 Participants
1 Participants
Percentage of Subjects With Pupil Diameter of < 3.5, < 3.0, < 2.5, < 2.0, and < 1.5 mm at Day 3 and Day 8
Day 3: < 3.5 mm
177 Participants
10 Participants
Percentage of Subjects With Pupil Diameter of < 3.5, < 3.0, < 2.5, < 2.0, and < 1.5 mm at Day 3 and Day 8
Day 8: < 3.5 mm
181 Participants
20 Participants
Percentage of Subjects With Pupil Diameter of < 3.5, < 3.0, < 2.5, < 2.0, and < 1.5 mm at Day 3 and Day 8
Day 3: < 2.0 mm
0 Participants
0 Participants
Percentage of Subjects With Pupil Diameter of < 3.5, < 3.0, < 2.5, < 2.0, and < 1.5 mm at Day 3 and Day 8
Day 8: < 2.0 mm
0 Participants
0 Participants
Percentage of Subjects With Pupil Diameter of < 3.5, < 3.0, < 2.5, < 2.0, and < 1.5 mm at Day 3 and Day 8
Day 3: < 1.5 mm
0 Participants
0 Participants
Percentage of Subjects With Pupil Diameter of < 3.5, < 3.0, < 2.5, < 2.0, and < 1.5 mm at Day 3 and Day 8
Day 8: < 1.5 mm
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 8 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 percentage of subjects with pupil diameter of 1.5 to \< 2.0 mm, 2.0 to \< 2.5 mm, 2.5 to \< 3.0 mm, and 3.0 to \< 3.5 mm at Day 3 and Day 8.

Outcome measures

Outcome measures
Measure
0.75% Phentolamine Ophthalmic Solution
n=341 Participants
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
n=228 Participants
phentolamine ophthalmic solution vehicle, Drug: Placebo
Percentage of Subjects With Pupil Diameter of 1.5 to < 2.0 mm, 2.0 to < 2.5 mm, 2.5 to < 3.0 mm, and 3.0 to < 3.5 mm at Day 3 and Day 8
Day 3: 1.5 to < 2.0 mm
0 Participants
0 Participants
Percentage of Subjects With Pupil Diameter of 1.5 to < 2.0 mm, 2.0 to < 2.5 mm, 2.5 to < 3.0 mm, and 3.0 to < 3.5 mm at Day 3 and Day 8
Day 8, 1.5 to < 2.0 mm
0 Participants
0 Participants
Percentage of Subjects With Pupil Diameter of 1.5 to < 2.0 mm, 2.0 to < 2.5 mm, 2.5 to < 3.0 mm, and 3.0 to < 3.5 mm at Day 3 and Day 8
Day 3: 2.0 to < 2.5 mm
16 Participants
0 Participants
Percentage of Subjects With Pupil Diameter of 1.5 to < 2.0 mm, 2.0 to < 2.5 mm, 2.5 to < 3.0 mm, and 3.0 to < 3.5 mm at Day 3 and Day 8
Day 8: 2.0 to < 2.5 mm
10 Participants
1 Participants
Percentage of Subjects With Pupil Diameter of 1.5 to < 2.0 mm, 2.0 to < 2.5 mm, 2.5 to < 3.0 mm, and 3.0 to < 3.5 mm at Day 3 and Day 8
Day 3: 2.5 to < 3.0 mm
70 Participants
2 Participants
Percentage of Subjects With Pupil Diameter of 1.5 to < 2.0 mm, 2.0 to < 2.5 mm, 2.5 to < 3.0 mm, and 3.0 to < 3.5 mm at Day 3 and Day 8
Day 8: 2.5 to < 3.0 mm
68 Participants
4 Participants
Percentage of Subjects With Pupil Diameter of 1.5 to < 2.0 mm, 2.0 to < 2.5 mm, 2.5 to < 3.0 mm, and 3.0 to < 3.5 mm at Day 3 and Day 8
Day 3: 3.0 to < 3.5 mm
91 Participants
8 Participants
Percentage of Subjects With Pupil Diameter of 1.5 to < 2.0 mm, 2.0 to < 2.5 mm, 2.5 to < 3.0 mm, and 3.0 to < 3.5 mm at Day 3 and Day 8
Day 8: 3.0 to < 3.5 mm
103 Participants
15 Participants
Percentage of Subjects With Pupil Diameter of 1.5 to < 2.0 mm, 2.0 to < 2.5 mm, 2.5 to < 3.0 mm, and 3.0 to < 3.5 mm at Day 3 and Day 8
Day 3: 2.4 to ≤ 3.5 mm
170 Participants
10 Participants
Percentage of Subjects With Pupil Diameter of 1.5 to < 2.0 mm, 2.0 to < 2.5 mm, 2.5 to < 3.0 mm, and 3.0 to < 3.5 mm at Day 3 and Day 8
Day 8: 2.4 to ≤ 3.5 mm
175 Participants
19 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 investigates the change from baseline in overall and component subject-reported outcomes at Day 3, Day 8, and Week 6. : Responses to each question used a 1-5 scale with 1=Worst outcome and 5=Best outcome.

Outcome measures

Outcome measures
Measure
0.75% Phentolamine Ophthalmic Solution
n=341 Participants
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
n=228 Participants
phentolamine ophthalmic solution vehicle, Drug: Placebo
Change From Baseline in Overall and Component Subject-Reported Outcomes at Day 3, Day 8, and Week 6
How often did you need to use or do something to help you read small-sized text at a near distance?
0.49 Scores on a Scale
Standard Deviation 0.05
0.30 Scores on a Scale
Standard Deviation 0.06
Change From Baseline in Overall and Component Subject-Reported Outcomes at Day 3, Day 8, and Week 6
My study medication made my near vision
3.63 Scores on a Scale
Standard Deviation 0.03
3.27 Scores on a Scale
Standard Deviation 0.04
Change From Baseline in Overall and Component Subject-Reported Outcomes at Day 3, Day 8, and Week 6
How convenient was it to use your study medication for your near vision
4.13 Scores on a Scale
Standard Deviation 0.05
4.16 Scores on a Scale
Standard Deviation 0.06
Change From Baseline in Overall and Component Subject-Reported Outcomes at Day 3, Day 8, and Week 6
How frequently would you use the study medication if it were available to you
4.29 Scores on a Scale
Standard Deviation 0.07
3.89 Scores on a Scale
Standard Deviation 0.09
Change From Baseline in Overall and Component Subject-Reported Outcomes at Day 3, Day 8, and Week 6
Day 8, How frequently would you use the study medication if it were available to you
4.04 Scores on a Scale
Standard Deviation 0.08
3.62 Scores on a Scale
Standard Deviation 0.10
Change From Baseline in Overall and Component Subject-Reported Outcomes at Day 3, Day 8, and Week 6
How satisfied are you with how long the effects of the study medication lasted throughout the day
3.39 Scores on a Scale
Standard Deviation 0.05
2.87 Scores on a Scale
Standard Deviation 0.06
Change From Baseline in Overall and Component Subject-Reported Outcomes at Day 3, Day 8, and Week 6
How satisfied are you with your study medication to help you see clearly up close when you
3.26 Scores on a Scale
Standard Deviation 0.06
2.69 Scores on a Scale
Standard Deviation 0.07
Change From Baseline in Overall and Component Subject-Reported Outcomes at Day 3, Day 8, and Week 6
My study medication made my near vision in dim/low light
3.45 Scores on a Scale
Standard Deviation 0.03
3.17 Scores on a Scale
Standard Deviation 0.04
Change From Baseline in Overall and Component Subject-Reported Outcomes at Day 3, Day 8, and Week 6
How frequently did you use some form of near vision correction?
0.27 Scores on a Scale
Standard Deviation 0.05
0.09 Scores on a Scale
Standard Deviation 0.06
Change From Baseline in Overall and Component Subject-Reported Outcomes at Day 3, Day 8, and Week 6
How often did you need to use or do something to help you read information on a cell phone at a...
0.37 Scores on a Scale
Standard Deviation 0.05
0.18 Scores on a Scale
Standard Deviation 0.06
Change From Baseline in Overall and Component Subject-Reported Outcomes at Day 3, Day 8, and Week 6
How often did you need to use or do something to help you read information on a computer screen...
0.49 Scores on a Scale
Standard Deviation 0.06
0.43 Scores on a Scale
Standard Deviation 0.07
Change From Baseline in Overall and Component Subject-Reported Outcomes at Day 3, Day 8, and Week 6
How likely would you be to use the study medication for near vision correction?
3.87 Scores on a Scale
Standard Deviation 0.07
3.49 Scores on a Scale
Standard Deviation 0.08

Adverse Events

0.75% Phentolamine Ophthalmic Solution

Serious events: 4 serious events
Other events: 158 other events
Deaths: 0 deaths

Phentolamine Ophthalmic Solution Vehicle

Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
0.75% Phentolamine Ophthalmic Solution
n=341 participants at risk
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
n=228 participants at risk
phentolamine ophthalmic solution vehicle, Drug: Placebo
Eye disorders
Retinal vein occlusion
0.29%
1/341 • For enrollment until the end of study, up to 48 weeks
0.00%
0/228 • For enrollment until the end of study, up to 48 weeks
Hepatobiliary disorders
Cholecystitis
0.29%
1/341 • For enrollment until the end of study, up to 48 weeks
0.00%
0/228 • For enrollment until the end of study, up to 48 weeks
Infections and infestations
Encephalitis bacterial
0.00%
0/341 • For enrollment until the end of study, up to 48 weeks
0.44%
1/228 • For enrollment until the end of study, up to 48 weeks
Infections and infestations
Septic shock
0.29%
1/341 • For enrollment until the end of study, up to 48 weeks
0.00%
0/228 • For enrollment until the end of study, up to 48 weeks
Injury, poisoning and procedural complications
Rib fracture
0.00%
0/341 • For enrollment until the end of study, up to 48 weeks
0.44%
1/228 • For enrollment until the end of study, up to 48 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
0.29%
1/341 • For enrollment until the end of study, up to 48 weeks
0.00%
0/228 • For enrollment until the end of study, up to 48 weeks
Nervous system disorders
Metabolic encephalopathy
0.29%
1/341 • For enrollment until the end of study, up to 48 weeks
0.00%
0/228 • For enrollment until the end of study, up to 48 weeks
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.00%
0/341 • For enrollment until the end of study, up to 48 weeks
0.44%
1/228 • For enrollment until the end of study, up to 48 weeks
Vascular disorders
Intracranial aneurysm
0.00%
0/341 • For enrollment until the end of study, up to 48 weeks
0.44%
1/228 • For enrollment until the end of study, up to 48 weeks

Other adverse events

Other adverse events
Measure
0.75% Phentolamine Ophthalmic Solution
n=341 participants at risk
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Phentolamine Ophthalmic Solution Vehicle
n=228 participants at risk
phentolamine ophthalmic solution vehicle, Drug: Placebo
Nervous system disorders
Headache
3.5%
12/341 • For enrollment until the end of study, up to 48 weeks
1.3%
3/228 • For enrollment until the end of study, up to 48 weeks
Infections and infestations
Nasopharyngitis
1.5%
5/341 • For enrollment until the end of study, up to 48 weeks
2.6%
6/228 • For enrollment until the end of study, up to 48 weeks
Immune system disorders
Drug hypersensitivity
3.2%
11/341 • For enrollment until the end of study, up to 48 weeks
0.00%
0/228 • For enrollment until the end of study, up to 48 weeks
Vascular disorders
Hypertension
2.3%
8/341 • For enrollment until the end of study, up to 48 weeks
3.5%
8/228 • For enrollment until the end of study, up to 48 weeks
Eye disorders
Conjunctival hyperaemia
27.9%
95/341 • For enrollment until the end of study, up to 48 weeks
1.8%
4/228 • For enrollment until the end of study, up to 48 weeks
Eye disorders
Visual acuity reduced
3.5%
12/341 • For enrollment until the end of study, up to 48 weeks
4.8%
11/228 • For enrollment until the end of study, up to 48 weeks
Eye disorders
Dry eye
4.1%
14/341 • For enrollment until the end of study, up to 48 weeks
3.1%
7/228 • For enrollment until the end of study, up to 48 weeks
Eye disorders
Eye irritation
6.2%
21/341 • For enrollment until the end of study, up to 48 weeks
0.00%
0/228 • For enrollment until the end of study, up to 48 weeks
Eye disorders
Eczema eyelids
5.3%
18/341 • For enrollment until the end of study, up to 48 weeks
0.00%
0/228 • For enrollment until the end of study, up to 48 weeks
Eye disorders
Eye pruritus
3.5%
12/341 • For enrollment until the end of study, up to 48 weeks
0.88%
2/228 • For enrollment until the end of study, up to 48 weeks
Eye disorders
Conjunctivitis allergic
3.5%
12/341 • For enrollment until the end of study, up to 48 weeks
0.44%
1/228 • For enrollment until the end of study, up to 48 weeks
Eye disorders
Eye discharge
3.2%
11/341 • For enrollment until the end of study, up to 48 weeks
0.00%
0/228 • For enrollment until the end of study, up to 48 weeks
Eye disorders
Hordeolum
1.5%
5/341 • For enrollment until the end of study, up to 48 weeks
2.6%
6/228 • For enrollment until the end of study, up to 48 weeks
Eye disorders
Eyelids pruritus
2.6%
9/341 • For enrollment until the end of study, up to 48 weeks
0.00%
0/228 • For enrollment until the end of study, up to 48 weeks
Eye disorders
Lacrimation increased
2.6%
9/341 • For enrollment until the end of study, up to 48 weeks
0.00%
0/228 • For enrollment until the end of study, up to 48 weeks
Eye disorders
Swelling of eyelid
2.3%
8/341 • For enrollment until the end of study, up to 48 weeks
0.00%
0/228 • For enrollment until the end of study, up to 48 weeks
Eye disorders
Blepharitis
2.1%
7/341 • For enrollment until the end of study, up to 48 weeks
0.00%
0/228 • For enrollment until the end of study, up to 48 weeks
Eye disorders
Foreign body sensation in eyes
2.1%
7/341 • For enrollment until the end of study, up to 48 weeks
0.00%
0/228 • For enrollment until the end of study, up to 48 weeks
General disorders
Instillation site irritation
16.1%
55/341 • For enrollment until the end of study, up to 48 weeks
1.3%
3/228 • For enrollment until the end of study, up to 48 weeks
General disorders
Instillation site erythema
4.4%
15/341 • For enrollment until the end of study, up to 48 weeks
0.00%
0/228 • For enrollment until the end of study, up to 48 weeks
Nervous system disorders
Dysgeusia
5.9%
20/341 • For enrollment until the end of study, up to 48 weeks
0.44%
1/228 • For enrollment until the end of study, up to 48 weeks

Additional Information

Study Director

Opus Genetics

Phone: 984-884-6030

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60