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Completed

NCT Number: NCT03131154

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

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.

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Key information

Conditions

Non-infectious Anterior Uveitis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UAB Department of Ophthalmology, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ADX-102 Ophthalmic Solution (0.5%)

Drug

ADX-102 Ophthalmic Solution (0.5%) administered for approximately four weeks.

Other names: Reproxalap

Vehicle of ADX-102 Ophthalmic Solution

Drug

Vehicle of ADX-102 Ophthalmic Solution administered for approximately four weeks.

Other names: Vehicle of Reproxlap

Primary outcomes

  1. Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells

    Time frame: The efficacy assessment period was 4 weeks; baseline was defined as Day 1.

    Time to clearance of anterior chamber cells was defined as the time from initiation of study drug to when a cell count of 0 was achieved and maintained (without cell count increases to >0) to Week 4 and without rescue or discontinuation due to rescue prior to Week 4. Anterior chamber cell count is the number of cells visible within the anterior chamber of the eye, measured using a slit lamp and following SUN (Standardization of Uveitis Nomenclature) where a cell count <1 is Grade 0 (absent) and a cell count of >50 is Grade 4+ (severe).

Sponsors and collaborators

Lead sponsor

Aldeyra Therapeutics, Inc.

Industry

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 27, 2017
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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