Trial Outcomes & Findings for The RENEW Trial: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease (NCT NCT03879863)
NCT ID: NCT03879863
Last Updated: 2025-01-23
Results Overview
Change from baseline comparison of reproxalap to vehicle for subject-reported ocular dryness score VAS (0 = no discomfort - 100 = maximal discomfort), where a higher score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline calculated using baseline score, treatment arm, visit, and the interaction of treatment arm and visit as fixed effects.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
422 participants
Primary outcome timeframe
The efficacy assessment period (Day 1 through 85) was assessed at Weeks 1, 2, 4, 6, 8, 10, and 12; baseline was Day 1.
Results posted on
2025-01-23
Participant Flow
Participant milestones
| Measure |
Reproxalap Ophthalmic Solution (0.25%) QID
Reproxalap ophthalmic solution administered QID (four times daily) for twelve weeks
|
Vehicle Ophthalmic Solution QID
Vehicle ophthalmic solution administered QID (four times daily) for twelve weeks
|
Reproxalap Ophthalmic Solution (0.25%) QID to BID
Reproxalap ophthalmic solution administered QID (four times daily) for four weeks, followed by BID (two times daily) administration for eight weeks
|
Vehicle Ophthalmic Solution QID to BID
Vehicle ophthalmic solution administered QID (four times daily) for four weeks, followed by BID (two times daily) administration for eight weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
105
|
106
|
105
|
106
|
|
Overall Study
COMPLETED
|
98
|
102
|
94
|
104
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
11
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The RENEW Trial: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease
Baseline characteristics by cohort
| Measure |
Reproxalap Ophthalmic Solution (0.25%) QID
n=105 Participants
Reproxalap ophthalmic solution administered QID for twelve weeks
|
Vehicle Ophthalmic Solution QID
n=106 Participants
Vehicle ophthalmic solution administered QID for twelve weeks
|
Reproxalap Ophthalmic Solution (0.25%) QID to BID
n=105 Participants
Reproxalap ophthalmic solution administered QID for four weeks, followed by BID administration for eight weeks
|
Vehicle Ophthalmic Solution QID to BID
n=106 Participants
Vehicle ophthalmic solution administered QID for four weeks, followed by BID administration for eight weeks
|
Total
n=422 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
182 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
65 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
240 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
312 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
389 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
92 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
363 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
105 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
422 Participants
n=21 Participants
|
|
Iris Color (Right Eye)
Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Iris Color (Right Eye)
Blue
|
32 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
|
Iris Color (Right Eye)
Brown
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
175 Participants
n=21 Participants
|
|
Iris Color (Right Eye)
Hazel
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Iris Color (Right Eye)
Gray
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Iris Color (Right Eye)
Green
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Iris Color (Right Eye)
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Iris Color (Left Eye)
Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Iris Color (Left Eye)
Blue
|
32 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
130 Participants
n=21 Participants
|
|
Iris Color (Left Eye)
Brown
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
175 Participants
n=21 Participants
|
|
Iris Color (Left Eye)
Hazel
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Iris Color (Left Eye)
Gray
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Iris Color (Left Eye)
Green
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Iris Color (Left Eye)
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: The efficacy assessment period (Day 1 through 85) was assessed at Weeks 1, 2, 4, 6, 8, 10, and 12; baseline was Day 1.Population: Intent-to-treat Ocular Dryness Population with observed data only
Change from baseline comparison of reproxalap to vehicle for subject-reported ocular dryness score VAS (0 = no discomfort - 100 = maximal discomfort), where a higher score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline calculated using baseline score, treatment arm, visit, and the interaction of treatment arm and visit as fixed effects.
Outcome measures
| Measure |
Reproxalap Ophthalmic Solution (0.25%) QID
n=85 Participants
Reproxalap ophthalmic solution administered QID for twelve weeks
|
Vehicle Ophthalmic Solution QID
n=86 Participants
Vehicle ophthalmic solution administered QID for twelve weeks
|
Reproxalap Ophthalmic Solution (0.25%) QID to BID
n=85 Participants
Reproxalap ophthalmic solution administered QID for four weeks, followed by BID administration for eight weeks
|
Vehicle Ophthalmic Solution QID to BID
n=85 Participants
Vehicle ophthalmic solution administered QID for four weeks, followed by BID administration for eight weeks
|
|---|---|---|---|---|
|
Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS))
|
-11.5 score on a scale
Standard Error 2.44
|
-15.0 score on a scale
Standard Error 2.39
|
-17.8 score on a scale
Standard Error 2.20
|
-6.8 score on a scale
Standard Error 2.12
|
PRIMARY outcome
Timeframe: The efficacy assessment period (Day 15 through 85) was assessed at Weeks 2, 4, 6, 8, 10, and 12; baseline was Day 1.Population: Intent-to-Treat Fluorescein Nasal Score Population with observed data only
Change from baseline comparison of reproxalap to vehicle for fluorescein staining of the nasal region (0 = none - 4 = severe), where a higher score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline calculated using baseline fluorescein nasal score, treatment arm, visit, and the interaction of treatment arm and visit as fixed effects.
Outcome measures
| Measure |
Reproxalap Ophthalmic Solution (0.25%) QID
n=91 Participants
Reproxalap ophthalmic solution administered QID for twelve weeks
|
Vehicle Ophthalmic Solution QID
n=90 Participants
Vehicle ophthalmic solution administered QID for twelve weeks
|
Reproxalap Ophthalmic Solution (0.25%) QID to BID
n=89 Participants
Reproxalap ophthalmic solution administered QID for four weeks, followed by BID administration for eight weeks
|
Vehicle Ophthalmic Solution QID to BID
n=90 Participants
Vehicle ophthalmic solution administered QID for four weeks, followed by BID administration for eight weeks
|
|---|---|---|---|---|
|
Fluorescein Nasal Region Score (0 = None - 4 = Severe)
|
-0.47 units on a scale
Standard Error 0.060
|
-0.46 units on a scale
Standard Error 0.058
|
-0.53 units on a scale
Standard Error 0.056
|
-0.46 units on a scale
Standard Error 0.053
|
Adverse Events
Reproxalap Ophthalmic Solution (0.25%) QID
Serious events: 3 serious events
Other events: 88 other events
Deaths: 0 deaths
Vehicle Ophthalmic Solution QID
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Reproxalap Ophthalmic Solution (0.25%) QID to BID
Serious events: 1 serious events
Other events: 94 other events
Deaths: 0 deaths
Vehicle Ophthalmic Solution QID to BID
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Reproxalap Ophthalmic Solution (0.25%) QID
n=105 participants at risk
Reproxalap ophthalmic solution administered QID for twelve weeks
|
Vehicle Ophthalmic Solution QID
n=106 participants at risk
Vehicle ophthalmic solution administered QID for twelve weeks
|
Reproxalap Ophthalmic Solution (0.25%) QID to BID
n=105 participants at risk
Reproxalap ophthalmic solution administered QID for four weeks, followed by BID administration for eight weeks
|
Vehicle Ophthalmic Solution QID to BID
n=106 participants at risk
Vehicle ophthalmic solution administered QID for four weeks, followed by BID administration for eight weeks
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/105 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/106 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/105 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.94%
1/106 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/105 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/106 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.95%
1/105 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/106 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.95%
1/105 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/106 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/105 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/106 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/105 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.94%
1/106 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/105 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/106 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/105 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/106 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/105 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.94%
1/106 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.95%
1/105 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/106 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/105 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/106 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/105 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.94%
1/106 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/105 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/106 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/105 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.94%
1/106 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/105 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/106 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
|
Infections and infestations
Pneumonia
|
0.95%
1/105 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/106 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/105 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.00%
0/106 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
Other adverse events
| Measure |
Reproxalap Ophthalmic Solution (0.25%) QID
n=105 participants at risk
Reproxalap ophthalmic solution administered QID for twelve weeks
|
Vehicle Ophthalmic Solution QID
n=106 participants at risk
Vehicle ophthalmic solution administered QID for twelve weeks
|
Reproxalap Ophthalmic Solution (0.25%) QID to BID
n=105 participants at risk
Reproxalap ophthalmic solution administered QID for four weeks, followed by BID administration for eight weeks
|
Vehicle Ophthalmic Solution QID to BID
n=106 participants at risk
Vehicle ophthalmic solution administered QID for four weeks, followed by BID administration for eight weeks
|
|---|---|---|---|---|
|
General disorders
General disorders and administration site conditions
|
83.8%
88/105 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
6.6%
7/106 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
89.5%
94/105 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
0.94%
1/106 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.
|
Additional Information
Sr. Director, Clinical Operations
Aldeyra Therapeutics, Inc.
Phone: 781-257-3063
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place