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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.