Non-infectious Anterior UveitisPhase 3NCT03131154
SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.
A Phase 3 study testing ADX-102 Ophthalmic Solution (0.5%) in people with Non-infectious Anterior Uveitis, run by Aldeyra Therapeutics, Inc. at 27 sites in United States.
Trial summary
A Phase 3, randomized, double-masked, vehicle-controlled trial to evaluate the safety and efficacy of ADX-102 ophthalmic solution in Subjects with non-infectious anterior-uveitis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non-infectious Anterior Uveitis
- What is being tested?
- ADX-102 Ophthalmic Solution (0.5%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 27 sitesUnited States
- Study dates
- 26 Apr 2017to 26 Apr 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥ 18 years and ≤ 85 years.
- Subjects with acute non-infectious anterior uveitis with onset of symptoms within the previous 2 weeks.
- Best corrected visual acuity (BCVA) better than or equal to 35 letters in the study eye and 65 letters in the non-study eye using ETDRS testing.
Who cannot join
- Have severe/serious ocular pathology in the study eye(s) which may preclude study completion, in the judgement of the Investigator.
- Active intermediate or posterior uveitis in the study eye(s).
- Previous anterior uveitis episode in the study eye ≤ 4 weeks prior to screening.
- Have participated in another investigational device or drug study within 30 days prior to screening.
- Participation in a prior ADX-102 study.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Valley Eye Physicians & Surgeons
Ayer, Massachusetts, 01432
John Hopkins
Baltimore, Maryland, 21205
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
UAB Department of Ophthalmology
Birmingham, Alabama, 35233
Oakland Ophthalmic Surgery
Birmingham, Michigan, 48009
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Texas Retina Associates
Dallas, Texas, 75231
Danbury Eye Physicians & Surgeons
Danbury, Connecticut, 06810
Oregon Retina, LLP
Eugene, Oregon, 97401
Bergstrom Eye Research
Fargo, North Dakota, 58103
Retina Consultants of Houston
Houston, Texas, 77030
Midwest Eye Institute
Indianapolis, Indiana, 46290
University of California, Irvine
Irvine, California, 92697
Levenson Eye Associates
Jacksonville, Florida, 33204
Tauber Eye Center
Kansas City, Missouri, 64111
Corneal Consultants of Colorado
Littleton, Colorado, 80120
Virginia Eye Consultants
Norfolk, Virginia, 23502
Metropolitan Eye Research and Surgery Institute
Palisades Park, New Jersey, 07650
Byers Eye Institute at Stanford University
Palo Alto, California, 85014
Retinal Research Institute
Phoenix, Arizona, 85014
M&M Eye Institute
Prescott, Arizona, 86301
Retinal Consultants Medical Group, Inc.
Sacramento, California, 95819
Retina and Uveitis Consultants of Texas
San Antonio, Texas, 78240
Walman Eye Center
Sun City, Arizona, 85351
Retina Consultants of Houston
The Woodlands, Texas, 77384
Ocular Immunology & Uveitis Foundation
Waltham, Massachusetts, 02451
Center for Retina and Macular Disease
Winter Haven, Florida, 33880
About this study
Official title: A Phase 3, Randomized, Double-masked, Vehicle-controlled Trial to Evaluate the Safety and Efficacy of ADX-102 Ophthalmic Solution in Subjects With Non-infectious Anterior-uveitis.
A Phase 3, randomized, double-masked, vehicle-controlled trial to evaluate the safety and efficacy of ADX-102 ophthalmic solution in Subjects with non-infectious anterior-uveitis.
- Conditions
- Non-infectious Anterior Uveitis
- Being tested
- ADX-102 Ophthalmic Solution (0.5%), Vehicle of ADX-102 Ophthalmic Solution
- Keywords
- reproxalap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADX-102 Ophthalmic Solution (0.5%)Drug
Also called Reproxalap
ADX-102 Ophthalmic Solution (0.5%) administered for approximately four weeks.
Vehicle of ADX-102 Ophthalmic SolutionDrug
Also called Vehicle of Reproxlap
Vehicle of ADX-102 Ophthalmic Solution administered for approximately four weeks.
| Study group | Role | What they receive |
|---|---|---|
| ADX-102 Ophthalmic Solution (0.5%) | Experimental | Not described Receives: Drug: ADX-102 Ophthalmic Solution (0.5%) |
| Vehicle of ADX-102 Ophthalmic Solution | Placebo comparator | Not described Receives: Drug: Vehicle of ADX-102 Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells
Time to clearance of anterior chamber cells was defined as the time from initiation of study drug to when a cell count of 0 was achieved and maintained (without cell count increases to >0) to Week 4 and without rescue or discontinuation due to rescue prior to Week 4. Anterior chamber cell count is the number of cells visible within the anterior chamber of the eye, measured using a slit lamp and following SUN (Standardization of Uveitis Nomenclature) where a cell count <1 is Grade 0 (absent) and a cell count of >50 is Grade 4+ (severe).
Measured: The efficacy assessment period was 4 weeks; baseline was defined as Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start26 Apr 2017
- Primary completion19 Apr 2019
- Study completion26 Apr 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.
- Other trials for Non-infectious Anterior UveitisStudies 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
- 123 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
- NCT03131154
- Sponsor's protocol ID
- ADX-102-UV-005
- Status last verified
- May 2020
- First submitted
- 4 Apr 2017
- Last updated
- 10 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-masked, Vehicle-controlled Trial to Evaluate the Safety and Efficacy of ADX-102 Ophthalmic Solution in Subjects With Non-infectious Anterior-uveitis.
- ClinicalTrials.gov ID
- NCT03131154
- Acronym / sponsor ID
- ADX-102-UV-005
- Conditions
- Non-infectious Anterior Uveitis
- Keywords
- reproxalap
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Aldeyra Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 19 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Posted 10 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 3, randomized, double-masked, vehicle-controlled trial to evaluate the safety and efficacy of ADX-102 ophthalmic solution in Subjects with non-infectious anterior-uveitis.
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 |
|---|---|---|
| ADX-102 Ophthalmic Solution (0.5%) | Experimental | Drug: ADX-102 Ophthalmic Solution (0.5%) |
| Vehicle of ADX-102 Ophthalmic Solution | Placebo comparator | Drug: Vehicle of ADX-102 Ophthalmic Solution |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects aged ≥ 18 years and ≤ 85 years.
- Subjects with acute non-infectious anterior uveitis with onset of symptoms within the previous 2 weeks.
- Best corrected visual acuity (BCVA) better than or equal to 35 letters in the study eye and 65 letters in the non-study eye using ETDRS testing.
Key exclusion criteria (5 listed)
- Have severe/serious ocular pathology in the study eye(s) which may preclude study completion, in the judgement of the Investigator.
- Active intermediate or posterior uveitis in the study eye(s).
- Previous anterior uveitis episode in the study eye ≤ 4 weeks prior to screening.
- Have participated in another investigational device or drug study within 30 days prior to screening.
- Participation in a prior ADX-102 study.
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 |
|---|---|---|
| ADX-102 Ophthalmic Solution (0.5%)Also: ReproxalapADX-102 Ophthalmic Solution (0.5%) administered for approximately four weeks. | Drug | ADX-102 Ophthalmic Solution (0.5%) |
| Vehicle of ADX-102 Ophthalmic SolutionAlso: Vehicle of ReproxlapVehicle of ADX-102 Ophthalmic Solution administered for approximately four weeks. | Drug | Vehicle of ADX-102 Ophthalmic Solution |
Primary outcome
Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells
Time frame: The efficacy assessment period was 4 weeks; baseline was defined as Day 1.
Time to clearance of anterior chamber cells was defined as the time from initiation of study drug to when a cell count of 0 was achieved and maintained (without cell count increases to >0) to Week 4 and without rescue or discontinuation due to rescue prior to Week 4. Anterior chamber cell count is the number of cells visible within the anterior chamber of the eye, measured using a slit lamp and following SUN (Standardization of Uveitis Nomenclature) where a cell count <1 is Grade 0 (absent) and a cell count of >50 is Grade 4+ (severe).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ADX-102 Ophthalmic Solution (0.5%) in people with Non-infectious Anterior Uveitis, run by Aldeyra Therapeutics, Inc. at 27 sites 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 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites 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 10 Feb 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?
Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells (time frame: The efficacy assessment period was 4 weeks; baseline was defined as Day 1.). 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 10 Feb 2025.