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

NCT03131154 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: ADX-102-UV-005
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 27

Brief Summary

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.

Conditions

Non-infectious Anterior Uveitis

Keywords

reproxalap

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells

  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).

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

Study Arms (2)

ADX-102 Ophthalmic Solution (0.5%)

EXPERIMENTAL

Drug: ADX-102 Ophthalmic Solution (0.5%)

Vehicle of ADX-102 Ophthalmic Solution

PLACEBO COMPARATOR

Drug: Vehicle of ADX-102 Ophthalmic Solution

Interventions

ADX-102 Ophthalmic Solution (0.5%) DRUG

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

Also known as: Reproxalap

ADX-102 Ophthalmic Solution (0.5%)

Vehicle of ADX-102 Ophthalmic Solution DRUG

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

Also known as: Vehicle of Reproxlap

Vehicle of ADX-102 Ophthalmic Solution

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aldeyra Therapeutics, Inc.: lead

Study Sites (27)

UAB Department of Ophthalmology

Birmingham, Alabama, 35233, United States

Location

Retinal Research Institute

Phoenix, Arizona, 85014, United States

Location

M&M Eye Institute

Prescott, Arizona, 86301, United States

Location

Walman Eye Center

Sun City, Arizona, 85351, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

University of California, Irvine

Irvine, California, 92697, United States

Location

Byers Eye Institute at Stanford University

Palo Alto, California, 85014, United States

Location

Retinal Consultants Medical Group, Inc.

Sacramento, California, 95819, United States

Location

Corneal Consultants of Colorado

Littleton, Colorado, 80120, United States

Location

Danbury Eye Physicians & Surgeons

Danbury, Connecticut, 06810, United States

Location

Levenson Eye Associates

Jacksonville, Florida, 33204, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Midwest Eye Institute

Indianapolis, Indiana, 46290, United States

Location

John Hopkins

Baltimore, Maryland, 21205, United States

Location

Valley Eye Physicians & Surgeons

Ayer, Massachusetts, 01432, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Ocular Immunology & Uveitis Foundation

Waltham, Massachusetts, 02451, United States

Location

Oakland Ophthalmic Surgery

Birmingham, Michigan, 48009, United States

Location

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Location

Metropolitan Eye Research and Surgery Institute

Palisades Park, New Jersey, 07650, United States

Location

Bergstrom Eye Research

Fargo, North Dakota, 58103, United States

Location

Oregon Retina, LLP

Eugene, Oregon, 97401, United States

Location

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

Retina and Uveitis Consultants of Texas

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Houston

The Woodlands, Texas, 77384, United States

Location

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Interventions

reproxalap

Results Point of Contact

• Title: Sr. Director, Clinical Operations
• Organization: Aldeyra Therapeutics, Inc.

bcavanagh@aldeyra.com

781-257-3063

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 27, 2017
• Study Start: April 26, 2017
• Primary Completion: April 19, 2019
• Study Completion: April 26, 2019
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (27)