SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.

Study Overview
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Brief Summary
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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.

Official Title
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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
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Non-infectious Anterior Uveitis

Intervention / Treatment
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* Drug: ADX-102 Ophthalmic Solution (0.5%)
* Drug: Vehicle of ADX-102 Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADX-102 Ophthalmic Solution (0.5%)<br> | Drug: ADX-102 Ophthalmic Solution (0.5%)<br>* ADX-102 Ophthalmic Solution (0.5%) administered for approximately four weeks.<br>* Other names: Reproxalap;|
| Placebo Comparator: Vehicle of ADX-102 Ophthalmic Solution<br> | Drug: Vehicle of ADX-102 Ophthalmic Solution<br>* Vehicle of ADX-102 Ophthalmic Solution administered for approximately four weeks.<br>* Other names: Vehicle of Reproxlap;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of ADX-102 on anterior chamber cell count using an anterior uveitis grading scale. | Evaluate the efficacy of ADX-102 Ophthalmic Solution on anterior chamber cell count in subjects with non-infectious anterior uveitis. | Efficacy assessment period (Day 1 through Day 29) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of ADX-102 on anterior chamber flare using an anterior uveitis grading scale. | Evaluate the signs and symptoms of ADX-102 Ophthalmic Solution on anterior chamber flare in subjects with non-infectious anterior uveitis. | Efficacy assessment period (Day 1 through Day 29) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reproxalap