Trial Outcomes & Findings for Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3 (NCT NCT03937882)
NCT ID: NCT03937882
Last Updated: 2026-08-28
Results Overview
Inferior corneal staining was assessed using the Ora Calibra® Corneal and Conjunctival Staining Scale, which is a 0 to 4 scale and where higher numbers indicating more severe staining.
COMPLETED
PHASE3
700 participants
Day 15
2026-08-28
Participant Flow
Subjects were screened during a 14-day study run-in period prior to randomization. And after run-in period and confirmation of inclusion and exclusion criteria, all eligible subjects were randomized in a 1:1 ratio to receive 0.1% RGN-259 or placebo ophthalmic solution bilaterally, four times per day (QID) for 14 days. The study comprised of 4 visits over the course of approximately 4 weeks
One participant was enrolled and completed the study twice and received placebo in both periods. This subject was counted once in the ITT population but twice in the safety population. Another participant randomized to the 0.1% RGN-259 arm did not receive treatment and was included only in the ITT population. Consequently, the ITT population included 351 participants in the 0.1% RGN-259 arm and 348 in the placebo arm; the safety population included 350 and 349 participants, respectively.
Participant milestones
| Measure |
Experimental: RGN-259
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into both eyes, four times per day for 14 days
|
Placebo Comparator: Placebo
It is composed of the same excipients as RGN-259 but does not contain Tβ4
|
|---|---|---|
|
Overall Study
STARTED
|
351
|
348
|
|
Overall Study
COMPLETED
|
346
|
343
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3
Baseline characteristics by cohort
| Measure |
Experimental: RGN-259
n=351 Participants
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into both eyes, four times per day for 14 days
|
Placebo Comparator: Placebo
n=348 Participants
It is composed of the same excipients as RGN-259 but does not contain Tβ4
|
Total
n=699 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.2 Years
STANDARD_DEVIATION 12.31 • n=31 Participants
|
62.5 Years
STANDARD_DEVIATION 12.36 • n=49 Participants
|
62.8 Years
STANDARD_DEVIATION 12.33 • n=80 Participants
|
|
Sex: Female, Male
Female
|
267 Participants
n=31 Participants
|
254 Participants
n=49 Participants
|
521 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=31 Participants
|
94 Participants
n=49 Participants
|
178 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
4 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=31 Participants
|
11 Participants
n=49 Participants
|
19 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
44 Participants
n=31 Participants
|
54 Participants
n=49 Participants
|
98 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
295 Participants
n=31 Participants
|
275 Participants
n=49 Participants
|
570 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=31 Participants
|
6 Participants
n=49 Participants
|
7 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=31 Participants
|
22 Participants
n=49 Participants
|
48 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
323 Participants
n=31 Participants
|
325 Participants
n=49 Participants
|
648 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
3 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: Day 15Inferior corneal staining was assessed using the Ora Calibra® Corneal and Conjunctival Staining Scale, which is a 0 to 4 scale and where higher numbers indicating more severe staining.
Outcome measures
| Measure |
Experimental: RGN-259
n=351 Participants
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into both eyes, four times per day for 14 days
|
Placebo Comparator: Placebo
n=348 Participants
It is composed of the same excipients as RGN-259 but does not contain Tβ4
|
|---|---|---|
|
Change From Baseline in Inferior Corneal Staining Change From Pre-CAE®(Controlled Adverse Environment) to Post-CAE® at Day 15 (Visit 4) Using the Ora Calibra® Scale
|
-0.41 Score on a scale
Standard Deviation 0.841
|
-0.46 Score on a scale
Standard Deviation 0.804
|
PRIMARY outcome
Timeframe: Day 15The severity of ocular discomfort was measured using the Ora Calibra® Ocular Discomfort \& 4-Symptom Questionnaire which is a 0 to 5 scale and where higher numbers indicating more severe discomfort.
Outcome measures
| Measure |
Experimental: RGN-259
n=351 Participants
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into both eyes, four times per day for 14 days
|
Placebo Comparator: Placebo
n=348 Participants
It is composed of the same excipients as RGN-259 but does not contain Tβ4
|
|---|---|---|
|
Change From Baseline in Ocular Discomfort at Day 15 (Visit 4) Pre-CAE® Using the Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire
|
-0.4 Score on a scale
Standard Deviation 1.12
|
-0.4 Score on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: Day 8, Day 15Population: Intent-to-treat population; number of participants analyzed varies by outcome due to missing assessments.
Corneal and conjunctival staining were assessed using the Ora Calibra® Corneal and Conjunctival Staining Scale, which is a 0 to 20 scale and where higher numbers indicating more severe staining.
Outcome measures
| Measure |
Experimental: RGN-259
n=351 Participants
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into both eyes, four times per day for 14 days
|
Placebo Comparator: Placebo
n=348 Participants
It is composed of the same excipients as RGN-259 but does not contain Tβ4
|
|---|---|---|
|
Fluorescein Staining (Ora Calibra® Scale) at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre and Post-CAE®)
Visit 4 (Day 15), Post-CAE
|
10.11 Score on a scale
Standard Deviation 3.052
|
9.95 Score on a scale
Standard Deviation 3.018
|
|
Fluorescein Staining (Ora Calibra® Scale) at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre and Post-CAE®)
Visit 4 (Day 15), Change from Pre-CAE to Post-CAE
|
1.91 Score on a scale
Standard Deviation 2.319
|
1.92 Score on a scale
Standard Deviation 2.262
|
|
Fluorescein Staining (Ora Calibra® Scale) at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre and Post-CAE®)
Visit 4 (Day 15), Pre-CAE
|
8.20 Score on a scale
Standard Deviation 2.996
|
8.06 Score on a scale
Standard Deviation 2.909
|
|
Fluorescein Staining (Ora Calibra® Scale) at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre and Post-CAE®)
Visit 3 (Day 8), Pre-CAE
|
8.46 Score on a scale
Standard Deviation 2.960
|
8.36 Score on a scale
Standard Deviation 2.885
|
SECONDARY outcome
Timeframe: Day 8, Day 15Population: Intent-to-treat population; number of participants analyzed varies by outcome due to missing assessments.
Lissamine green staining were assessed using the Ora Calibra® Corneal and Conjunctival Staining Scale, which is a 0 to 20 scale and where higher numbers indicating more severe staining.
Outcome measures
| Measure |
Experimental: RGN-259
n=351 Participants
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into both eyes, four times per day for 14 days
|
Placebo Comparator: Placebo
n=348 Participants
It is composed of the same excipients as RGN-259 but does not contain Tβ4
|
|---|---|---|
|
Lissamine Green Staining (Ora Calibra® Scale) at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre- and Post-CAE®)
Visit 3 (Day 8), Pre-CAE
|
5.71 Score on a scale
Standard Deviation 3.192
|
5.71 Score on a scale
Standard Deviation 3.106
|
|
Lissamine Green Staining (Ora Calibra® Scale) at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre- and Post-CAE®)
Visit 4 (Day 15), Post-CAE
|
7.03 Score on a scale
Standard Deviation 3.406
|
6.70 Score on a scale
Standard Deviation 3.246
|
|
Lissamine Green Staining (Ora Calibra® Scale) at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre- and Post-CAE®)
Visit 4 (Day 15), Change from Pre-CAE to Post-CAE
|
1.69 Score on a scale
Standard Deviation 2.281
|
1.54 Score on a scale
Standard Deviation 2.289
|
|
Lissamine Green Staining (Ora Calibra® Scale) at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre- and Post-CAE®)
Visit 4 (Day 15), Pre-CAE
|
5.34 Score on a scale
Standard Deviation 3.149
|
5.18 Score on a scale
Standard Deviation 2.961
|
SECONDARY outcome
Timeframe: Day 8, Day 15Population: Intent-to-treat population; number of participants analyzed varies by outcome due to missing assessments.
TFBUT© measures tear film stability and was assessed by measuring, in seconds, the time from eye opening to the formation of micelles in the tear film. Measurements were obtained using a stopwatch. Longer TFBUT values indicate greater tear film stability and less severe dry eye.
Outcome measures
| Measure |
Experimental: RGN-259
n=351 Participants
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into both eyes, four times per day for 14 days
|
Placebo Comparator: Placebo
n=348 Participants
It is composed of the same excipients as RGN-259 but does not contain Tβ4
|
|---|---|---|
|
Tear Film Break-Up Time (TFBUT©) at Visits 3 and 4 (Pre- and Post-CAE®)
Visit 4 (Day 15), Post-CAE
|
3.1072 Seconds
Standard Deviation 1.36872
|
3.1739 Seconds
Standard Deviation 1.43102
|
|
Tear Film Break-Up Time (TFBUT©) at Visits 3 and 4 (Pre- and Post-CAE®)
Visit 3 (Day 8), Pre-CAE
|
3.1782 Seconds
Standard Deviation 1.34370
|
3.2186 Seconds
Standard Deviation 1.20830
|
|
Tear Film Break-Up Time (TFBUT©) at Visits 3 and 4 (Pre- and Post-CAE®)
Visit 4 (Day 15), Pre-CAE
|
3.1210 Seconds
Standard Deviation 1.48605
|
3.1237 Seconds
Standard Deviation 1.34341
|
SECONDARY outcome
Timeframe: Day 8, Day 15Population: Intent-to-treat population; number of participants analyzed varies by outcome due to missing assessments.
The Unanesthetized Schirmer's Test measures tear production. A sterile Schirmer test strip was placed in the lower temporal lid margin of each eye, and after 5 minutes, the length of the moistened area on the strip was recorded in millimeters (mm). Higher values indicate greater tear production and a better outcome.
Outcome measures
| Measure |
Experimental: RGN-259
n=351 Participants
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into both eyes, four times per day for 14 days
|
Placebo Comparator: Placebo
n=348 Participants
It is composed of the same excipients as RGN-259 but does not contain Tβ4
|
|---|---|---|
|
Unanesthetized Schirmer's Test at Visit 3, Visit 4 (Pre-CAE®)
Visit 3 (Day 8), Pre-CAE
|
5.3 mm
Standard Deviation 4.36
|
5.9 mm
Standard Deviation 5.05
|
|
Unanesthetized Schirmer's Test at Visit 3, Visit 4 (Pre-CAE®)
Visit 4 (Day 15), Pre-CAE
|
5.6 mm
Standard Deviation 4.75
|
6.0 mm
Standard Deviation 6.13
|
SECONDARY outcome
Timeframe: Day 1Population: Intent-to-treat population; number of participants analyzed varies by outcome due to missing assessments.
Drop comfort for each eye was assessed using subject-reported drop comfort scale, which is a 0 to 10 scale and where higher numbers indicating more uncomfortable.
Outcome measures
| Measure |
Experimental: RGN-259
n=349 Participants
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into both eyes, four times per day for 14 days
|
Placebo Comparator: Placebo
n=348 Participants
It is composed of the same excipients as RGN-259 but does not contain Tβ4
|
|---|---|---|
|
Drop Comfort Assessment After Randomization at Visit 2
|
2.2 Score on a scale
Standard Deviation 2.31
|
2.0 Score on a scale
Standard Deviation 2.23
|
SECONDARY outcome
Timeframe: Day 8, Day 15Population: Intent-to-treat population; number of participants analyzed varies by outcome due to missing assessments.
The severity of dry eye disease and its impact on vision-related function were measured using the Ocular Surface Disease Index. Scores range from 0 to 100, with higher scores indicating greater disability.
Outcome measures
| Measure |
Experimental: RGN-259
n=351 Participants
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into both eyes, four times per day for 14 days
|
Placebo Comparator: Placebo
n=348 Participants
It is composed of the same excipients as RGN-259 but does not contain Tβ4
|
|---|---|---|
|
Ocular Surface Disease Index (OSDI)© at Visits 3 and 4 (Pre-CAE®)
Total OSDI Score - Visit 3 (Day 8)
|
32.2 Score on a scale
Standard Deviation 19.74
|
33.7 Score on a scale
Standard Deviation 19.64
|
|
Ocular Surface Disease Index (OSDI)© at Visits 3 and 4 (Pre-CAE®)
Total OSDI Score - Visit 4 (Day 15)
|
31.3 Score on a scale
Standard Deviation 19.79
|
32.3 Score on a scale
Standard Deviation 19.87
|
SECONDARY outcome
Timeframe: Day 8, Day 15Population: Intent-to-treat population; number of participants analyzed varies by outcome due to missing assessments.
The severity of 5 symptoms was measured using the Ora Calibra® Ocular Discomfort \& 4-Symptom Questionnaire which is a 0 to 5 scale and where higher numbers indicating more severe discomfort.
Outcome measures
| Measure |
Experimental: RGN-259
n=351 Participants
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into both eyes, four times per day for 14 days
|
Placebo Comparator: Placebo
n=348 Participants
It is composed of the same excipients as RGN-259 but does not contain Tβ4
|
|---|---|---|
|
Ocular Discomfort & 4-Symptom Questionnaire at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre- and Post-CAE®), Excluding the Hierarchical Efficacy Measure
Ocular Discomfort - Visit 3 (Day 8), Pre-CAE
|
2.4 Score
Standard Deviation 1.19
|
2.4 Score
Standard Deviation 1.15
|
|
Ocular Discomfort & 4-Symptom Questionnaire at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre- and Post-CAE®), Excluding the Hierarchical Efficacy Measure
Ocular Discomfort - Visit 4 (Day 15), Pre-CAE
|
2.3 Score
Standard Deviation 1.20
|
2.3 Score
Standard Deviation 1.21
|
|
Ocular Discomfort & 4-Symptom Questionnaire at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre- and Post-CAE®), Excluding the Hierarchical Efficacy Measure
Ocular Discomfort - Visit 4 (Day 15), Post-CAE
|
3.3 Score
Standard Deviation 0.98
|
3.4 Score
Standard Deviation 0.96
|
|
Ocular Discomfort & 4-Symptom Questionnaire at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre- and Post-CAE®), Excluding the Hierarchical Efficacy Measure
Ocular Discomfort - Visit 4 (Day 15), Change from Pre-CAE to Post-CAE
|
1.1 Score
Standard Deviation 1.28
|
1.1 Score
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Day 8, Day 15Population: Intent-to-treat population; number of participants analyzed varies by outcome due to missing assessments.
Subjects' perceived severity of ocular discomfort was measured using the Ocular Discomfort Scale which is a 0 to 4 scale and where higher numbers indicating more severe discomfort.
Outcome measures
| Measure |
Experimental: RGN-259
n=351 Participants
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into both eyes, four times per day for 14 days
|
Placebo Comparator: Placebo
n=348 Participants
It is composed of the same excipients as RGN-259 but does not contain Tβ4
|
|---|---|---|
|
Ocular Discomfort Outside CAE® at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre- and Post-CAE®)
Visit 3 (Day 8), Pre-CAE
|
2.3 Score on a scale
Standard Deviation 1.16
|
2.2 Score on a scale
Standard Deviation 1.12
|
|
Ocular Discomfort Outside CAE® at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre- and Post-CAE®)
Visit 4 (Day 15), Change from Pre-CAE to Post-CAE
|
1.2 Score on a scale
Standard Deviation 1.27
|
1.2 Score on a scale
Standard Deviation 1.36
|
|
Ocular Discomfort Outside CAE® at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre- and Post-CAE®)
Visit 4 (Day 15), Pre-CAE
|
2.1 Score on a scale
Standard Deviation 1.13
|
2.1 Score on a scale
Standard Deviation 1.19
|
|
Ocular Discomfort Outside CAE® at Visits 3 and 4 (Change From Pre-CAE® to Post-CAE®, Pre- and Post-CAE®)
Visit 4 (Day 15), Post-CAE
|
3.3 Score on a scale
Standard Deviation 0.92
|
3.3 Score on a scale
Standard Deviation 0.88
|
SECONDARY outcome
Timeframe: Day 15Population: Intent-to-treat population; number of participants analyzed varies by outcome due to missing assessments.
Subjects' perceived severity of ocular discomfort during CAE® exposure was measured using the Ocular Discomfort Scale which is a 0 to 4 scale and where higher numbers indicating more severe discomfort.
Outcome measures
| Measure |
Experimental: RGN-259
n=344 Participants
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into both eyes, four times per day for 14 days
|
Placebo Comparator: Placebo
n=332 Participants
It is composed of the same excipients as RGN-259 but does not contain Tβ4
|
|---|---|---|
|
Ocular Discomfort During CAE® at Visit 4
|
1.5 Score on a scale
Standard Deviation 1.11
|
1.7 Score on a scale
Standard Deviation 1.06
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day -14 ± 1 day, Day 1, Day 8, Day 15Population: Visual acuity is a safety assessment and all safety assessments were analyzed using the safety population, which differed from the intent-to-treat (ITT) population that included all randomized subjects, due to one participant in placebo arm who was consented, enrolled twice, and another participant in 0.1% RGN-259 arm who was randomized, but not treated.
LogMAR Visual acuity was measured using ETDRS chart at Visits 1, 2, 3 and 4 and represented in LogMAR.
Outcome measures
| Measure |
Experimental: RGN-259
n=350 Participants
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into both eyes, four times per day for 14 days
|
Placebo Comparator: Placebo
n=349 Participants
It is composed of the same excipients as RGN-259 but does not contain Tβ4
|
|---|---|---|
|
Visual Acuity (Using an ETDRS (Early Treatment of Diabetic Retinopathy Study) Chart) at Visits 1, 2, 3 and 4
BCVA (Better Corrected Visual Acuity) in study eye at Visit 1 (Day -14)
|
0.135 logMAR
Standard Deviation 0.1568
|
0.128 logMAR
Standard Deviation 0.1424
|
|
Visual Acuity (Using an ETDRS (Early Treatment of Diabetic Retinopathy Study) Chart) at Visits 1, 2, 3 and 4
BCVA in study eye at Visit 2 (Day 1)
|
0.134 logMAR
Standard Deviation 0.1658
|
0.120 logMAR
Standard Deviation 0.1504
|
|
Visual Acuity (Using an ETDRS (Early Treatment of Diabetic Retinopathy Study) Chart) at Visits 1, 2, 3 and 4
BCVA in study eye at Visit 3 (Day 8)
|
0.124 logMAR
Standard Deviation 0.1637
|
0.112 logMAR
Standard Deviation 0.1499
|
|
Visual Acuity (Using an ETDRS (Early Treatment of Diabetic Retinopathy Study) Chart) at Visits 1, 2, 3 and 4
BCVA in study eye at Visit 4 (Day 15)
|
0.118 logMAR
Standard Deviation 0.1629
|
0.106 logMAR
Standard Deviation 0.1466
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day -14 ± 1 day, Day 1, Day 8, Day 15Population: Slit-lamp biomicroscopy is a safety assessment and all safety assessments were analyzed using the safety population, which differed from the intent-to-treat (ITT) population that included all randomized subjects, due to one participant in placebo arm who was consented, enrolled twice, and another participant in 0.1% RGN-259 arm who was randomized, but not treated.
Slit-lamp biomicroscopy at Visits 1, 2, 3 and 4
Outcome measures
| Measure |
Experimental: RGN-259
n=350 Participants
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into both eyes, four times per day for 14 days
|
Placebo Comparator: Placebo
n=349 Participants
It is composed of the same excipients as RGN-259 but does not contain Tβ4
|
|---|---|---|
|
Slit-lamp Biomicroscopy at Visits 1, 2, 3 and 4
Abnormal findings at Visit 1 (Day -14), Pre-CAE
|
1 Participants
|
0 Participants
|
|
Slit-lamp Biomicroscopy at Visits 1, 2, 3 and 4
Abnormal findings at Visit 1 (Day -14), Post-CAE
|
1 Participants
|
0 Participants
|
|
Slit-lamp Biomicroscopy at Visits 1, 2, 3 and 4
Abnormal findings at Visit 2 (Day 1), Pre-CAE
|
1 Participants
|
0 Participants
|
|
Slit-lamp Biomicroscopy at Visits 1, 2, 3 and 4
Abnormal findings at Visit 2 (Day 1), Post-CAE
|
1 Participants
|
0 Participants
|
|
Slit-lamp Biomicroscopy at Visits 1, 2, 3 and 4
Abnormal findings at Visit 3 (Day 8), Pre-CAE
|
1 Participants
|
0 Participants
|
|
Slit-lamp Biomicroscopy at Visits 1, 2, 3 and 4
Abnormal findings at Visit 4 (Day 15), Pre-CAE
|
1 Participants
|
0 Participants
|
|
Slit-lamp Biomicroscopy at Visits 1, 2, 3 and 4
Abnormal findings at Visit 4 (Day 15), Post-CAE
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day -14 ± 1 day, Day 15Population: Corneal Sensitivity is a safety assessment and all safety assessments were analyzed using the safety population, which differed from the intent-to-treat (ITT) population that included all randomized subjects, due to one participant in placebo arm who was consented, enrolled twice, and another participant in 0.1% RGN-259 arm who was randomized, but not treated.
Corneal sensitivity was measured using a Cochet-Bonnet esthesiometer by applying gentle pressure to the central corneal surface and recording the filament length (mm) at which the subject perceived the sensation. Higher values (longer filament lengths) indicate greater corneal sensitivity and a better outcome.
Outcome measures
| Measure |
Experimental: RGN-259
n=350 Participants
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into both eyes, four times per day for 14 days
|
Placebo Comparator: Placebo
n=349 Participants
It is composed of the same excipients as RGN-259 but does not contain Tβ4
|
|---|---|---|
|
Corneal Sensitivity at Visits 1 and 4 (Pre-CAE®)
Corneal sensitivity in study eye at Visit 1 (Day -14)
|
57.8 mm
Standard Deviation 5.89
|
58.2 mm
Standard Deviation 4.70
|
|
Corneal Sensitivity at Visits 1 and 4 (Pre-CAE®)
Corneal sensitivity in study eye at Visit 4 (Day 15)
|
57.5 mm
Standard Deviation 7.11
|
58.4 mm
Standard Deviation 4.32
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day -14 ± 1 day, Day 15Population: Undilated Fundoscopy is a safety assessment and all safety assessments were analyzed using the safety population, which differed from the intent-to-treat (ITT) population that included all randomized subjects, due to one participant in placebo arm who was consented, enrolled twice, and another participant in 0.1% RGN-259 arm who was randomized, but not treated.
Undilated Fundoscopy at Visits 1 and 4
Outcome measures
| Measure |
Experimental: RGN-259
n=350 Participants
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into both eyes, four times per day for 14 days
|
Placebo Comparator: Placebo
n=349 Participants
It is composed of the same excipients as RGN-259 but does not contain Tβ4
|
|---|---|---|
|
Undilated Fundoscopy at Visits 1 and 4
Abnormal findings in study eye at baseline Visit 1 (Day -14)
|
0 Participants
|
0 Participants
|
|
Undilated Fundoscopy at Visits 1 and 4
Abnormal findings in study eye at Visit 4 (Day 15)
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day -14 ± 1 day, Day 15Population: Intraocular Pressure is a safety assessment and all safety assessments were analyzed using the safety population, which differed from the intent-to-treat (ITT) population that included all randomized subjects, due to one participant in placebo arm who was consented, enrolled twice, and another participant in 0.1% RGN-259 arm who was randomized, but not treated.
Intraocular Pressure (mmHg) at Visits 1 and 4
Outcome measures
| Measure |
Experimental: RGN-259
n=350 Participants
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into both eyes, four times per day for 14 days
|
Placebo Comparator: Placebo
n=349 Participants
It is composed of the same excipients as RGN-259 but does not contain Tβ4
|
|---|---|---|
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Intraocular Pressure at Visits 1 and 4
Intraocular Pressure in study eye at Visit 1 (Day -14)
|
14.5 mmHg
Standard Deviation 2.65
|
14.8 mmHg
Standard Deviation 2.83
|
|
Intraocular Pressure at Visits 1 and 4
Intraocular Pressure in study eye at Visit 4 (Day 15)
|
14.5 mmHg
Standard Deviation 2.79
|
14.8 mmHg
Standard Deviation 2.96
|
Adverse Events
Experimental: RGN-259
Placebo Comparator: Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental: RGN-259
n=350 participants at risk
It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into both eyes, four times per day for 14 days
|
Placebo Comparator: Placebo
n=349 participants at risk
It is composed of the same excipients as RGN-259 but does not contain Tβ4
|
|---|---|---|
|
General disorders
Instillation site pain
|
6.6%
23/350 • Adverse events were collected at every visit through study completion, approximately 4 weeks.
The safety population included 699 subjects. One participant completed the study twice and received placebo in both periods; this subject was counted once in the ITT population but twice in the safety population. Another participant randomized to the 0.1% RGN-259 arm was not treated and was included only in the ITT population. Accordingly, the ITT population comprised 351 in the 0.1% RGN-259 arm and 348 in the placebo arm, while the safety population comprised 350 and 349, respectively.
|
4.6%
16/349 • Adverse events were collected at every visit through study completion, approximately 4 weeks.
The safety population included 699 subjects. One participant completed the study twice and received placebo in both periods; this subject was counted once in the ITT population but twice in the safety population. Another participant randomized to the 0.1% RGN-259 arm was not treated and was included only in the ITT population. Accordingly, the ITT population comprised 351 in the 0.1% RGN-259 arm and 348 in the placebo arm, while the safety population comprised 350 and 349, respectively.
|
|
General disorders
Instillation site irritation
|
1.4%
5/350 • Adverse events were collected at every visit through study completion, approximately 4 weeks.
The safety population included 699 subjects. One participant completed the study twice and received placebo in both periods; this subject was counted once in the ITT population but twice in the safety population. Another participant randomized to the 0.1% RGN-259 arm was not treated and was included only in the ITT population. Accordingly, the ITT population comprised 351 in the 0.1% RGN-259 arm and 348 in the placebo arm, while the safety population comprised 350 and 349, respectively.
|
0.57%
2/349 • Adverse events were collected at every visit through study completion, approximately 4 weeks.
The safety population included 699 subjects. One participant completed the study twice and received placebo in both periods; this subject was counted once in the ITT population but twice in the safety population. Another participant randomized to the 0.1% RGN-259 arm was not treated and was included only in the ITT population. Accordingly, the ITT population comprised 351 in the 0.1% RGN-259 arm and 348 in the placebo arm, while the safety population comprised 350 and 349, respectively.
|
|
Eye disorders
Visual acuity reduced
|
3.4%
12/350 • Adverse events were collected at every visit through study completion, approximately 4 weeks.
The safety population included 699 subjects. One participant completed the study twice and received placebo in both periods; this subject was counted once in the ITT population but twice in the safety population. Another participant randomized to the 0.1% RGN-259 arm was not treated and was included only in the ITT population. Accordingly, the ITT population comprised 351 in the 0.1% RGN-259 arm and 348 in the placebo arm, while the safety population comprised 350 and 349, respectively.
|
2.0%
7/349 • Adverse events were collected at every visit through study completion, approximately 4 weeks.
The safety population included 699 subjects. One participant completed the study twice and received placebo in both periods; this subject was counted once in the ITT population but twice in the safety population. Another participant randomized to the 0.1% RGN-259 arm was not treated and was included only in the ITT population. Accordingly, the ITT population comprised 351 in the 0.1% RGN-259 arm and 348 in the placebo arm, while the safety population comprised 350 and 349, respectively.
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
7/350 • Adverse events were collected at every visit through study completion, approximately 4 weeks.
The safety population included 699 subjects. One participant completed the study twice and received placebo in both periods; this subject was counted once in the ITT population but twice in the safety population. Another participant randomized to the 0.1% RGN-259 arm was not treated and was included only in the ITT population. Accordingly, the ITT population comprised 351 in the 0.1% RGN-259 arm and 348 in the placebo arm, while the safety population comprised 350 and 349, respectively.
|
1.7%
6/349 • Adverse events were collected at every visit through study completion, approximately 4 weeks.
The safety population included 699 subjects. One participant completed the study twice and received placebo in both periods; this subject was counted once in the ITT population but twice in the safety population. Another participant randomized to the 0.1% RGN-259 arm was not treated and was included only in the ITT population. Accordingly, the ITT population comprised 351 in the 0.1% RGN-259 arm and 348 in the placebo arm, while the safety population comprised 350 and 349, respectively.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place