Dry Eye DiseasePhase 3NCT06424444
A Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease
A Phase 3 study testing Reproxalap ophthalmic solution (0.25%) in people with Dry Eye Disease, run by Aldeyra Therapeutics, Inc. at 1 site in United States.
Trial summary
A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Reproxalap ophthalmic solution (0.25%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 421 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2024to 3 Nov 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- at least 18 years of age;
- written informed consent and sign the Health Information Portability and Accountability Act (HIPAA) form;
- history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1
Who cannot join
- ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1;
- contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the trial;
- eye drops within 2 hours of Visit 1;
- laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
- topical ocular cyclosporine, lifitegrast, corticosteroid, or any other topical ocular prescription medication within 90 days of Visit 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap
- Conditions
- Dry Eye Disease
- Being tested
- Reproxalap ophthalmic solution (0.25%), Vehicle ophthalmic solution
- 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%)Drug
Reproxalap ophthalmic solution (0.25%) administered QID for four weeks, followed by BID administration for two weeks
Vehicle ophthalmic solutionDrug
Vehicle ophthalmic solution administered QID for four weeks, followed by BID administration for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) | Experimental | Not described Receives: Drug: Reproxalap ophthalmic solution (0.25%) |
| Vehicle Ophthalmic Solution | Placebo comparator | Not described Receives: Drug: Vehicle ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject-reported ocular discomfort score over Week 1 to Week 6
Measured using a 0 - 100 visual analog scale where 0 is "no discomfort" and 100 is "maximal discomfort"
Measured: From Day -14 to Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start29 Apr 2024
- Primary completion3 Nov 2024
- Study completion3 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aldeyra Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424444
- Sponsor's protocol ID
- ADX-102-DED-031
- Status last verified
- Sep 2025
- First submitted
- 17 May 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT06424444
- Acronym / sponsor ID
- ADX-102-DED-031
- Conditions
- Dry Eye Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- Aldeyra Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 3 Nov 2024 (actual)
- Study completion
- 3 Nov 2024 (actual)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) | Experimental | Drug: Reproxalap ophthalmic solution (0.25%) |
| Vehicle Ophthalmic Solution | Placebo comparator | Drug: Vehicle ophthalmic solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 years of age;
- written informed consent and sign the Health Information Portability and Accountability Act (HIPAA) form;
- history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1
Key exclusion criteria (5 listed)
- ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1;
- contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the trial;
- eye drops within 2 hours of Visit 1;
- laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
- topical ocular cyclosporine, lifitegrast, corticosteroid, or any other topical ocular prescription medication within 90 days of Visit 1
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%)Reproxalap ophthalmic solution (0.25%) administered QID for four weeks, followed by BID administration for two weeks | Drug | Reproxalap Ophthalmic Solution (0.25%) |
| Vehicle ophthalmic solutionVehicle ophthalmic solution administered QID for four weeks, followed by BID administration for two weeks | Drug | Vehicle Ophthalmic Solution |
Primary outcome
Subject-reported ocular discomfort score over Week 1 to Week 6
Time frame: From Day -14 to Day 43
Measured using a 0 - 100 visual analog scale where 0 is "no discomfort" and 100 is "maximal discomfort"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- 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?
A Phase 3 study testing Reproxalap ophthalmic solution (0.25%) in people with Dry Eye Disease, run by Aldeyra Therapeutics, Inc. at 1 site in United States.
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 5 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 1 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 discomfort score over Week 1 to Week 6 (time frame: From Day -14 to Day 43). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2025.