CompletedNCT03879863Updated Jan 23, 2025Results posted

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

A Phase 3 interventional study of Reproxalap Ophthalmic Solution (0.25%) QID and Vehicle Ophthalmic Solution QID in Dry Eye, sponsored by Aldeyra Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-23.

Sponsored by Aldeyra Therapeutics, Inc. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 422
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The RENEW Trial is a Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap 0.25% Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Conditions studied

Dry Eye

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In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's enrollment of 422 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

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Lead sponsor

Aldeyra Therapeutics, Inc. is the lead sponsor of 33 studies on the registry; 1 is open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 22 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Be at least 18 years of age of either gender and any race;
Have a reported history of dry eye for at least 6 months prior to Visit 1;
Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1

Exclusion criteria

Exclusion Criteria:

Have any clinically significant slit-lamp findings at Visit 1, including active blepharitis; meibomian gland dysfunction (MGD); lid margin inflammation; or active ocular allergies that require therapeutic treatment, or, in the opinion of the investigator may interfere with the assessment of the safety or efficacy of reproxalap or vehicle;
Have or be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1;
Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
Have used any eye drops within 2 hours of Visit 1;
Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
Have used ophthalmic cyclosporine or lifitegrast 5.0% ophthalmic solution within 90 days of Visit 1;
Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
Have used temporary or permanent punctal plugs within 30 days prior to Visit 1 or anticipate their use during the study period

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 422 participants (actual)

Study arms

Experimental
Reproxalap Ophthalmic Solution (0.25%) QID
Drug: Reproxalap Ophthalmic Solution (0.25%) QID
Placebo comparator
Vehicle Ophthalmic Solution QID
Drug: Vehicle Ophthalmic Solution QID
Experimental
Reproxalap Ophthalmic Solution (0.25%) QID to BID
Drug: Reproxalap Ophthalmic Solution (0.25%) QID to BID
Placebo comparator
Vehicle Ophthalmic Solution QID to BID
Drug: Vehicle Ophthalmic Solution QID to BID

Interventions

DrugReproxalap Ophthalmic Solution (0.25%) QID
Reproxalap Ophthalmic Solution (0.25%) administered QID for twelve weeks
DrugVehicle Ophthalmic Solution QID
Vehicle Ophthalmic Solution administered QID for twelve weeks
DrugReproxalap Ophthalmic Solution (0.25%) QID to BID
Reproxalap Ophthalmic Solution (0.25%) administered QID for four weeks, followed by BID administration for eight weeks
DrugVehicle Ophthalmic Solution QID to BID
Vehicle Ophthalmic Solution administered QID for four weeks, followed by BID administration for eight weeks

What researchers measure

Primary outcomes

Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS))
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.
Time frame: The efficacy assessment period (Day 1 through 85) was assessed at Weeks 1, 2, 4, 6, 8, 10, and 12; baseline was Day 1.
Fluorescein Nasal Region Score (0 = None - 4 = Severe)
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.
Time frame: The efficacy assessment period (Day 15 through 85) was assessed at Weeks 2, 4, 6, 8, 10, and 12; baseline was Day 1.

Results

Posted Jan 23, 2025

Participant flow

Participant flow — Overall Study
Milestone	Reproxalap Ophthalmic Solution (0.25%) QID	Vehicle Ophthalmic Solution QID	Reproxalap Ophthalmic Solution (0.25%) QID to BID	Vehicle Ophthalmic Solution QID to BID
Started	105	106	105	106
Completed	98	102	94	104
Not completed	7	4	11	2

Outcome measures

PrimarySubject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS))

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.

Time frame:: The efficacy assessment period (Day 1 through 85) was assessed at Weeks 1, 2, 4, 6, 8, 10, and 12; baseline was Day 1.
Reported as:: Least squares mean · score on a scale

Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS))
score on a scale	Reproxalap Ophthalmic Solution (0.25%) QID	Vehicle Ophthalmic Solution QID	Reproxalap Ophthalmic Solution (0.25%) QID to BID	Vehicle Ophthalmic Solution QID to BID
Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS))	-11.5 ± 2.44	-15.0 ± 2.39	-17.8 ± 2.20	-6.8 ± 2.12

PrimaryFluorescein Nasal Region Score (0 = None - 4 = Severe)

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.

Time frame:: The efficacy assessment period (Day 15 through 85) was assessed at Weeks 2, 4, 6, 8, 10, and 12; baseline was Day 1.
Reported as:: Least squares mean · units on a scale

Fluorescein Nasal Region Score (0 = None - 4 = Severe)
units on a scale	Reproxalap Ophthalmic Solution (0.25%) QID	Vehicle Ophthalmic Solution QID	Reproxalap Ophthalmic Solution (0.25%) QID to BID	Vehicle Ophthalmic Solution QID to BID
Fluorescein Nasal Region Score (0 = None - 4 = Severe)	-0.47 ± 0.060	-0.46 ± 0.058	-0.53 ± 0.056	-0.46 ± 0.053

Adverse events

Collected over The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Reproxalap Ophthalmic Solution (0.25%) QID	0/105 (0%)	3/105 (2.9%)	88/105 (83.8%)
Vehicle Ophthalmic Solution QID	0/106 (0%)	3/106 (2.8%)	7/106 (6.6%)
Reproxalap Ophthalmic Solution (0.25%) QID to BID	0/105 (0%)	1/105 (1%)	94/105 (89.5%)
Vehicle Ophthalmic Solution QID to BID	0/106 (0%)	2/106 (1.9%)	1/106 (0.9%)

Most frequent serious events

Most frequent serious events
Event	Reproxalap Ophthalmic Solution (0.25%) QID	Vehicle Ophthalmic Solution QID	Reproxalap Ophthalmic Solution (0.25%) QID to BID	Vehicle Ophthalmic Solution QID to BID
Acute kidney injuryRenal and urinary disorders	0/105	0/106	1/105	0/106
Gastroenteritis salmonellaInfections and infestations	1/105	0/106	0/105	0/106
HypoxiaRespiratory, thoracic and mediastinal disorders	1/105	0/106	0/105	0/106
PneumoniaInfections and infestations	1/105	0/106	0/105	0/106
Spinal compression fractureInjury, poisoning and procedural complications	0/105	0/106	0/105	1/106
Peripheral arterial occlusive diseaseVascular disorders	0/105	1/106	0/105	0/106
Cerebrovascular accidentNervous system disorders	0/105	0/106	0/105	1/106
Acute respiratory failureRespiratory, thoracic and mediastinal disorders	0/105	1/106	0/105	0/106
OsteomyelitisInfections and infestations	0/105	1/106	0/105	0/106

Most frequent other events

Most frequent other events
Event	Reproxalap Ophthalmic Solution (0.25%) QID	Vehicle Ophthalmic Solution QID	Reproxalap Ophthalmic Solution (0.25%) QID to BID	Vehicle Ophthalmic Solution QID to BID
General disorders and administration site conditionsGeneral disorders	88/105	7/106	94/105	1/106

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Reproxalap Ophthalmic Solution (0.25%) QID	Vehicle Ophthalmic Solution QID	Reproxalap Ophthalmic Solution (0.25%) QID to BID	Vehicle Ophthalmic Solution QID to BID	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	40	50	43	49	182
>=65 years	65	56	62	57	240

Sex: Female, Male
Sex: Female, Male(Participants)	Reproxalap Ophthalmic Solution (0.25%) QID	Vehicle Ophthalmic Solution QID	Reproxalap Ophthalmic Solution (0.25%) QID to BID	Vehicle Ophthalmic Solution QID to BID	Total
Female	78	77	75	82	312
Male	27	29	30	24	110

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Reproxalap Ophthalmic Solution (0.25%) QID	Vehicle Ophthalmic Solution QID	Reproxalap Ophthalmic Solution (0.25%) QID to BID	Vehicle Ophthalmic Solution QID to BID	Total
Hispanic or Latino	9	8	8	8	33
Not Hispanic or Latino	96	98	97	98	389
Unknown or Not Reported	0	0	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Reproxalap Ophthalmic Solution (0.25%) QID	Vehicle Ophthalmic Solution QID	Reproxalap Ophthalmic Solution (0.25%) QID to BID	Vehicle Ophthalmic Solution QID to BID	Total
American Indian or Alaska Native	0	3	0	0	3
Asian	4	4	8	9	25
Black or African American	7	7	6	7	27
Native Hawaiian or Other Pacific Islander	0	1	0	0	1
White	92	91	90	90	363
Multiple	1	0	0	0	1
Other	1	0	1	0	2

Region of Enrollment
Region of Enrollment(Participants)	Reproxalap Ophthalmic Solution (0.25%) QID	Vehicle Ophthalmic Solution QID	Reproxalap Ophthalmic Solution (0.25%) QID to BID	Vehicle Ophthalmic Solution QID to BID	Total
United States	105	106	105	106	422

Iris Color (Right Eye)
Iris Color (Right Eye)(Participants)	Reproxalap Ophthalmic Solution (0.25%) QID	Vehicle Ophthalmic Solution QID	Reproxalap Ophthalmic Solution (0.25%) QID to BID	Vehicle Ophthalmic Solution QID to BID	Total
Black	1	1	0	1	3
Blue	32	38	34	26	130
Brown	41	37	44	53	175
Hazel	18	20	13	12	63
Gray	1	0	0	2	3
Green	12	10	14	12	48
Other	0	0	0	0	0

Iris Color (Left Eye)
Iris Color (Left Eye)(Participants)	Reproxalap Ophthalmic Solution (0.25%) QID	Vehicle Ophthalmic Solution QID	Reproxalap Ophthalmic Solution (0.25%) QID to BID	Vehicle Ophthalmic Solution QID to BID	Total
Black	1	1	0	1	3
Blue	32	38	34	26	130
Brown	41	37	44	53	175
Hazel	18	20	13	12	63
Gray	1	0	0	2	3
Green	12	10	14	12	48
Other	0	0	0	0	0

Study locations

1 site

Eye Research Foundation
Newport Beach, California 92663, United States

References and documents

Study documents

Study protocol · Mar 5, 2019
Statistical analysis plan · Oct 31, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03879863
Lead sponsor: Aldeyra Therapeutics, Inc.
Responsible party: Sponsor
First posted: Mar 19, 2019
Start date: Apr 16, 2019
Primary completion: Oct 4, 2019
Completion: Oct 4, 2019
Results posted: Jan 23, 2025
Last update: Jan 23, 2025

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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