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

Aldeyra Therapeutics

Status and phase: Completed; Phase 3

Conditions: Non-infectious Anterior Uveitis

Treatments: Drug: ADX-102 Ophthalmic Solution (0.5%); Drug: Vehicle of ADX-102 Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT03131154

ADX-102-UV-005

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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123 participants in 2 patient groups, including a placebo group

ADX-102 Ophthalmic Solution (0.5%)

Experimental group

Treatment:

Drug: ADX-102 Ophthalmic Solution (0.5%)

Vehicle of ADX-102 Ophthalmic Solution

Placebo Comparator group

Treatment:

Drug: Vehicle of ADX-102 Ophthalmic Solution