Non-infectious Anterior Uveitis
Conditions
Keywords
reproxalap
Brief 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.
Interventions
ADX-102 Ophthalmic Solution (0.5%) administered for approximately four weeks.
DRUGVehicle of ADX-102 Ophthalmic Solution
Vehicle of ADX-102 Ophthalmic Solution administered for approximately four weeks.
Sponsors
Aldeyra Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ADX-102 Ophthalmic Solution (0.5%) ADX-102 administered for approximately 4 weeks | 61 |
| Vehicle Ophthalmic Solution Vehicle administered for approximately 4 weeks | 62 |
| Total | 123 |
Baseline characteristics
| Characteristic | ADX-102 Ophthalmic Solution (0.5%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| Age, Continuous | 45.3 years STANDARD_DEVIATION 15.8 | 47.8 years STANDARD_DEVIATION 17.9 | 46.5 years STANDARD_DEVIATION 16.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 22 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 40 Participants | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 167.09 centimeters STANDARD_DEVIATION 9.72 | 169.30 centimeters STANDARD_DEVIATION 9.57 | 168.2 centimeters STANDARD_DEVIATION 9.67 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 8 Participants | 10 Participants | 18 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 50 Participants | 48 Participants | 98 Participants |
| Region of Enrollment United States | 61 participants | 62 participants | 123 participants |
| Sex: Female, Male Female | 34 Participants | 41 Participants | 75 Participants |
| Sex: Female, Male Male | 27 Participants | 21 Participants | 48 Participants |
| Subjects with Bilateral Uveitis Both Eyes | 6 participants | 5 participants | 11 participants |
| Subjects with Bilateral Uveitis Left Eye | 30 participants | 34 participants | 64 participants |
| Subjects with Bilateral Uveitis Right Eye | 25 participants | 23 participants | 48 participants |
| Weight | 85.95 kilograms STANDARD_DEVIATION 20.62 | 85.45 kilograms STANDARD_DEVIATION 21.98 | 85.70 kilograms STANDARD_DEVIATION 21.23 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 62 |
| other Total, other adverse events | 36 / 61 | 31 / 62 |
| serious Total, serious adverse events | 1 / 61 | 2 / 62 |
Outcome results
Primary
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.
Population: Intent-to-treat population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ADX-102 Ophthalmic Solution (0.5%) | Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells | 25 Subjects |
| Vehicle Ophthalmic Solution | Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells | 24 Subjects |
95% CI: [0.643, 1.982]
Post Hoc
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
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.
Population: Intent-to-treat population in grade 1+ or grade 2+ subjects with a baseline anterior chamber cell count \> 10
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ADX-102 Ophthalmic Solution (0.5%) | 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 Subjects |
| 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 | 6 Subjects |
95% CI: [0.989, 6.939]