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

Purpose

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.

Condition

  • Non-infectious Anterior Uveitis

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
    Other names:
    • Reproxalap
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.
    Other names:
    • Vehicle of Reproxlap

More Details

Status
Completed
Sponsor
Aldeyra Therapeutics, Inc.

Study Contact