Dry EyePhase 3NCT03879863

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 study testing Reproxalap Ophthalmic Solution (0.25%) QID and Reproxalap Ophthalmic Solution (0.25%) QID to BID in people with Dry Eye, run by Aldeyra Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye
What is being tested?: Reproxalap Ophthalmic Solution (0.25%) QID and Reproxalap Ophthalmic Solution (0.25%) QID to BID
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 422 participants
Where: 1 siteUnited States
Study dates: 16 Apr 2019to 4 Oct 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Eye Research Foundation
Newport Beach, California, 92663

Other trials in United States

About this study

Official title: 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 Reproxalap 0.25% Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

Conditions: Dry Eye
Being tested: Reproxalap Ophthalmic Solution (0.25%) QID, Vehicle Ophthalmic Solution QID, Reproxalap Ophthalmic Solution (0.25%) QID to BID, Vehicle Ophthalmic Solution QID to BID
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03879863
Study group	Role	What they receive
Reproxalap Ophthalmic Solution (0.25%) QID	Experimental	Not described Receives: Drug: Reproxalap Ophthalmic Solution (0.25%) QID
Vehicle Ophthalmic Solution QID	Placebo comparator	Not described Receives: Drug: Vehicle Ophthalmic Solution QID
Reproxalap Ophthalmic Solution (0.25%) QID to BID	Experimental	Not described Receives: Drug: Reproxalap Ophthalmic Solution (0.25%) QID to BID
Vehicle Ophthalmic Solution QID to BID	Placebo comparator	Not described Receives: Drug: Vehicle Ophthalmic Solution QID to BID

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: The efficacy assessment period (Day 15 through 85) was assessed at Weeks 2, 4, 6, 8, 10, and 12; baseline was Day 1.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Apr 20194 Oct 2019

First posted19 Mar 2019
Study start16 Apr 2019
Primary completion4 Oct 2019
Study completion4 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dry EyeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 422 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03879863
Sponsor's protocol ID: ADX-102-DED-012
Status last verified: Jan 2025
First submitted: 15 Mar 2019
Last updated: 23 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Sheppard JD, Nichols K, Starr CE, Lewis A, Owen D, Zhao C, Li M, Cavanagh B, Brady TC. Effect of Reproxalap Treatment on Dry Eye Disease Symptoms: Analysis of Pooled Data From Two Randomized, Vehicle-Controlled, 12-Week Clinical Trials. Ophthalmol Ther. 2026 Sep 28. doi: 10.1007/s40123-026-01503-0. Online ahead of print.
PubMed 42803882

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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 Reproxalap 0.25% Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
ClinicalTrials.gov ID: NCT03879863
Acronym / sponsor ID: ADX-102-DED-012
Conditions: Dry Eye
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 422 participants (actual)
Lead sponsor: Aldeyra Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 16 Apr 2019 (actual)
Primary completion: 4 Oct 2019 (actual)
Study completion: 4 Oct 2019 (actual)
First posted: 19 Mar 2019 (actual)
Results: Posted 23 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Reproxalap Ophthalmic Solution (0.25%) QIDReproxalap Ophthalmic Solution (0.25%) administered QID for twelve weeks	Drug	Reproxalap Ophthalmic Solution (0.25%) QID
Vehicle Ophthalmic Solution QIDVehicle Ophthalmic Solution administered QID for twelve weeks	Drug	Vehicle Ophthalmic Solution QID
Reproxalap Ophthalmic Solution (0.25%) QID to BIDReproxalap Ophthalmic Solution (0.25%) administered QID for four weeks, followed by BID administration for eight weeks	Drug	Reproxalap Ophthalmic Solution (0.25%) QID to BID
Vehicle Ophthalmic Solution QID to BIDVehicle Ophthalmic Solution administered QID for four weeks, followed by BID administration for eight weeks	Drug	Vehicle Ophthalmic Solution QID to BID

Primary outcome

Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS))
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.
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.
Fluorescein Nasal Region Score (0 = None - 4 = Severe)
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.
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.

Results and safety

Results posted to the registry on 23 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Reproxalap Ophthalmic Solution (0.25%) QID	105	98
Vehicle Ophthalmic Solution QID	106	102
Reproxalap Ophthalmic Solution (0.25%) QID to BID	105	94
Vehicle Ophthalmic Solution QID to BID	106	104

Primary outcome: Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS))

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.. Least squares mean (Standard Error). Unit: score on a scale

Measure	Reproxalap Ophthalmic Solution (0.25%) QID n = 85	Vehicle Ophthalmic Solution QID n = 86	Reproxalap Ophthalmic Solution (0.25%) QID to BID n = 85	Vehicle Ophthalmic Solution QID to BID n = 85
Value	-11.5 (2.44)	-15.0 (2.39)	-17.8 (2.20)	-6.8 (2.12)

Population analysed: Intent-to-treat Ocular Dryness Population with observed data only

Primary outcome: Fluorescein Nasal Region Score (0 = None - 4 = Severe)

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.. Least squares mean (Standard Error). Unit: units on a scale

Measure	Reproxalap Ophthalmic Solution (0.25%) QID n = 91	Vehicle Ophthalmic Solution QID n = 90	Reproxalap Ophthalmic Solution (0.25%) QID to BID n = 89	Vehicle Ophthalmic Solution QID to BID n = 90
Value	-0.47 (0.060)	-0.46 (0.058)	-0.53 (0.056)	-0.46 (0.053)

Population analysed: Intent-to-Treat Fluorescein Nasal Score Population with observed data only

Adverse events

Time frame: The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Reproxalap Ophthalmic Solution (0.25%) QID	3 of 105 (2.9%)	88 of 105 (83.8%)	0 of 105
Vehicle Ophthalmic Solution QID	3 of 106 (2.8%)	7 of 106 (6.6%)	0 of 106
Reproxalap Ophthalmic Solution (0.25%) QID to BID	1 of 105 (1%)	94 of 105 (89.5%)	0 of 105
Vehicle Ophthalmic Solution QID to BID	2 of 106 (1.9%)	1 of 106 (0.9%)	0 of 106

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42803882Sheppard JD, Nichols K, Starr CE, Lewis A, Owen D, Zhao C, Li M, Cavanagh B, Brady TC. Effect of Reproxalap Treatment on Dry Eye Disease Symptoms: Analysis of Pooled Data From Two Randomized, Vehicle-Controlled, 12-Week Clinical Trials. Ophthalmol Ther. 2026 Sep 28. doi: 10.1007/s40123-026-01503-0. Online ahead of print.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS)) (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03879863, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.