A Phase 3 interventional study of ADX-102 Ophthalmic Solution (0.5%) and Vehicle of ADX-102 Ophthalmic Solution in Non-infectious Anterior Uveitis, sponsored by Aldeyra Therapeutics, Inc.. Completed at 27 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by Aldeyra Therapeutics, Inc. · Phase 3, Interventional, and Treatment
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.
335 studies on the registry are indexed under Uveitis; 37 are open to participants now.
This study's enrollment of 123 is above the median of 30 across 208 interventional studies indexed under Uveitis.
Browse Uveitis studies →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.
Exclusion Criteria:
Drug: ADX-102 Ophthalmic Solution (0.5%)
Drug: Vehicle of ADX-102 Ophthalmic Solution
ADX-102 Ophthalmic Solution (0.5%) administered for approximately four weeks.
Also known as: Reproxalap
Vehicle of ADX-102 Ophthalmic Solution administered for approximately four weeks.
Also known as: Vehicle of Reproxlap
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).
Time frame: The efficacy assessment period was 4 weeks; baseline was defined as Day 1.
| Milestone | ADX-102 Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution |
|---|---|---|
| Started | 61 | 62 |
| Completed | 37 | 33 |
| Not completed | 24 | 29 |
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).
| Subjects | ADX-102 Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution |
|---|---|---|
| Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells | 25 | 24 |
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).
| Subjects | ADX-102 Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution |
|---|---|---|
| Number of Subjects With Time to Clearance of Anterior Chamber Cells in Grade 1+ or Grade 2+ Subjects With a Baseline Anterior Chamber Cell Count > 10 | 13 | 6 |
Collected over The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ADX-102 Ophthalmic Solution (0.5%) | 0/61 (0%) | 1/61 (1.6%) | 36/61 (59%) |
| Vehicle Ophthalmic Solution | 0/62 (0%) | 2/62 (3.2%) | 31/62 (50%) |
| Event | ADX-102 Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution |
|---|---|---|
| Suicide AttemptPsychiatric disorders | 1/61 | 0/62 |
| Visual acuity reducedEye disorders | 0/61 | 1/62 |
| SyncopeNervous system disorders | 0/61 | 1/62 |
| Event | ADX-102 Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution |
|---|---|---|
| General Disorders and Administration Site ConditionsGeneral disorders | 13/61 | 0/62 |
| UveitisEye disorders | 7/61 | 7/62 |
| Eye painEye disorders | 7/61 | 7/62 |
| Visual acuity reducedEye disorders | 3/61 | 6/62 |
| IridocyclitisEye disorders | 4/61 | 3/62 |
| Eye inflammationEye disorders | 2/61 | 4/62 |
| Vitreous floatersEye disorders | 0/61 | 4/62 |
| Age, Continuous(years) | ADX-102 Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| Mean | 45.3 ± 15.8 | 47.8 ± 17.9 | 46.5 ± 16.9 |
| Sex: Female, Male(Participants) | ADX-102 Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| Female | 34 | 41 | 75 |
| Male | 27 | 21 | 48 |
| Ethnicity (NIH/OMB)(Participants) | ADX-102 Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| Hispanic or Latino | 27 | 22 | 49 |
| Not Hispanic or Latino | 34 | 40 | 74 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | ADX-102 Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| White | 50 | 48 | 98 |
| Black or African American | 8 | 10 | 18 |
| Asian | 0 | 1 | 1 |
| American Indian or Alaska Native | 1 | 0 | 1 |
| Unknown | 1 | 0 | 1 |
| Other | 1 | 3 | 4 |
| Region of Enrollment(participants) | ADX-102 Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| United States | 61 | 62 | 123 |
| Height(centimeters) | ADX-102 Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| Mean | 167.09 ± 9.72 | 169.30 ± 9.57 | 168.2 ± 9.67 |
| Weight(kilograms) | ADX-102 Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| Mean | 85.95 ± 20.62 | 85.45 ± 21.98 | 85.70 ± 21.23 |
| Subjects with Bilateral Uveitis(participants) | ADX-102 Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| Right Eye | 25 | 23 | 48 |
| Left Eye | 30 | 34 | 64 |
| Both Eyes | 6 | 5 | 11 |
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Aldeyra Therapeutics, Inc.