Dry Eye DiseasePhase 3NCT06389214
A Clinical Trial to Assess the Efficacy and Safety 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 Canada.
Trial summary
A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease Read more about this study
- Who is it for?
- Ages 18 to 70 years
- 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
- 132 participants
- Where
- 1 siteCanada
- Study dates
- 9 Apr 2024to 11 Jun 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eighteen to 70 years of age at the time of screening (either gender and any race)
- Ability to provide written informed consent
- Reported history of ocular discomfort associated with dry eye disease for at least 6 months prior to Visit 1
- Reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to Visit 1
Who cannot join
- Clinically significant slit lamp findings, intraocular pressure, and visual acuity findings at Visit 2 that may include active blepharitis, severe meibomian gland dysfunction, lid margin inflammation, glaucoma, ocular allergy, infection or any other disorder that, in the opinion of the Investigator, may interfere with trial conduct or assessments
- Diagnosis at Visit 1 of an ongoing ocular infection (bacterial, viral, or fungal), active ocular inflammation, or history of inflammatory disease that, in the opinion of the Investigator, could interfere with trial conduct or assessments
- Contact lens use within 7 days of Visit 1 or anticipated use of contact lenses during the trial
- Laser-assisted in situ keratomileusis (LASIK) surgery within 12 months of Visit 1 and/or planned ocular and/or lid surgeries during the trial or any other ocular surgery within 6 months of Visit 1
- Systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of Visit 1, or any planned immunomodulatory therapy during the trial
- Eye drop use within 2 weeks of Visit 1 and/or an unwillingness to discontinue any topical ophthalmic prescription or over-the-counter solutions, artificial tears, gels, or scrubs for the duration of the trial (excluding medications allowed for the conduct of the trial)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease
Read the detailed description
Dry eye chamber challenge trial.
- Conditions
- Dry Eye Disease
- Being tested
- Reproxalap Ophthalmic Solution (0.25%), Vehicle Ophthalmic Solution
- Keywords
- dry eye, reproxalap
- 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 six times over two consecutive days
Vehicle Ophthalmic SolutionDrug
Vehicle Ophthalmic Solution administered six times over two consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) administered six times over two consecutive days | Experimental | Not described Receives: Drug: Reproxalap Ophthalmic Solution (0.25%) |
| Vehicle Ophthalmic Solution administered six times over two consecutive days | 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.
Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 2 and Visit 4
Measured using a 0 - 100 visual analog scale (VAS) where 0 is "no discomfort" and 100 is "maximal discomfort"
Measured: From Day -14 to Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start9 Apr 2024
- Primary completion11 Jun 2024
- Study completion11 Jun 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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aldeyra Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Couroux, MD, Principal investigator, Cliantha Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389214
- Sponsor's protocol ID
- ADX-102-DED-030
- Status last verified
- Jun 2025
- First submitted
- 25 Apr 2024
- Last updated
- 5 Jun 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 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT06389214
- Acronym / sponsor ID
- ADX-102-DED-030
- Conditions
- Dry Eye Disease
- Keywords
- dry eye, reproxalap
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Aldeyra Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 11 Jun 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 29 Apr 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 Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease
Detailed description
Dry eye chamber challenge trial.
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%) administered six times over two consecutive days | Experimental | Drug: Reproxalap Ophthalmic Solution (0.25%) |
| Vehicle Ophthalmic Solution administered six times over two consecutive days | Placebo comparator | Drug: Vehicle Ophthalmic Solution |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eighteen to 70 years of age at the time of screening (either gender and any race)
- Ability to provide written informed consent
- Reported history of ocular discomfort associated with dry eye disease for at least 6 months prior to Visit 1
- Reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to Visit 1
Key exclusion criteria (6 listed)
- Clinically significant slit lamp findings, intraocular pressure, and visual acuity findings at Visit 2 that may include active blepharitis, severe meibomian gland dysfunction, lid margin inflammation, glaucoma, ocular allergy, infection or any other disorder that, in the opinion of the Investigator, may interfere with trial conduct or assessments
- Diagnosis at Visit 1 of an ongoing ocular infection (bacterial, viral, or fungal), active ocular inflammation, or history of inflammatory disease that, in the opinion of the Investigator, could interfere with trial conduct or assessments
- Contact lens use within 7 days of Visit 1 or anticipated use of contact lenses during the trial
- Laser-assisted in situ keratomileusis (LASIK) surgery within 12 months of Visit 1 and/or planned ocular and/or lid surgeries during the trial or any other ocular surgery within 6 months of Visit 1
- Systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of Visit 1, or any planned immunomodulatory therapy during the trial
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 six times over two consecutive days | Drug | Reproxalap Ophthalmic Solution (0.25%) administered six times over two consecutive days |
| Vehicle Ophthalmic SolutionVehicle Ophthalmic Solution administered six times over two consecutive days | Drug | Vehicle Ophthalmic Solution administered six times over two consecutive days |
Primary outcome
Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 2 and Visit 4
Time frame: From Day -14 to Day 2
Measured using a 0 - 100 visual analog scale (VAS) 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 5 Jun 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.
Patricia Couroux, MD principal investigator
Cliantha Research
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 Canada.
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 4 inclusion and 6 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 5 Jun 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 Canada. 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?
Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 2 and Visit 4 (time frame: From Day -14 to Day 2). 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 5 Jun 2025.