SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.
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|ClinicalTrials.gov Identifier: NCT03131154|
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : March 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-infectious Anterior Uveitis||Drug: ADX-102 Ophthalmic Solution (0.5%) Drug: Vehicle of ADX-102 Ophthalmic Solution||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Actual Study Start Date :||April 26, 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
|Experimental: ADX-102 Ophthalmic Solution (0.5%)||
Drug: ADX-102 Ophthalmic Solution (0.5%)
ADX-102 Ophthalmic Solution (0.5%) administered for approximately four weeks.
|Placebo Comparator: Vehicle of ADX-102 Ophthalmic Solution||
Drug: Vehicle of ADX-102 Ophthalmic Solution
Vehicle of ADX-102 Ophthalmic Solution administered for approximately four weeks.
- Efficacy of ADX-102 on anterior chamber cell count using an anterior uveitis grading scale. [ Time Frame: Efficacy assessment period (Day 1 through Day 29) ]Evaluate the efficacy of ADX-102 Ophthalmic Solution on anterior chamber cell count in subjects with non-infectious anterior uveitis.
- Efficacy of ADX-102 on anterior chamber flare using an anterior uveitis grading scale. [ Time Frame: Efficacy assessment period (Day 1 through Day 29) ]Evaluate the signs and symptoms of ADX-102 Ophthalmic Solution on anterior chamber flare in subjects with non-infectious anterior uveitis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131154
|Contact: Bill Cavanagh, MSemail@example.com|
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