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.

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.

Study Overview

• Status: Completed
• Conditions: Non-infectious Anterior Uveitis
• Intervention / Treatment: Drug: ADX-102 Ophthalmic Solution (0.5%); Drug: Vehicle of ADX-102 Ophthalmic Solution

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • UAB Department of Ophthalmology
  • Arizona
    • Phoenix, Arizona, United States, 85014
      • Retinal Research Institute
    • Prescott, Arizona, United States, 86301
      • M&M Eye Institute
    • Sun City, Arizona, United States, 85351
      • Walman Eye Center
  • California
    • Beverly Hills, California, United States, 90211
      • Retina-Vitreous Associates Medical Group
    • Irvine, California, United States, 92697
      • University of California, Irvine
    • Palo Alto, California, United States, 85014
      • Byers Eye Institute at Stanford University
    • Sacramento, California, United States, 95819
      • Retinal Consultants Medical Group, Inc.
  • Colorado
    • Littleton, Colorado, United States, 80120
      • Corneal Consultants of Colorado
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Danbury Eye Physicians & Surgeons
  • Florida
    • Jacksonville, Florida, United States, 33204
      • Levenson Eye Associates
    • Winter Haven, Florida, United States, 33880
      • Center for Retina and Macular Disease
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Midwest Eye Institute
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • John Hopkins
  • Massachusetts
    • Ayer, Massachusetts, United States, 01432
      • Valley Eye Physicians & Surgeons
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston
    • Waltham, Massachusetts, United States, 02451
      • Ocular Immunology & Uveitis Foundation
  • Michigan
    • Birmingham, Michigan, United States, 48009
      • Oakland Ophthalmic Surgery
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Tauber Eye Center
  • New Jersey
    • Palisades Park, New Jersey, United States, 07650
      • Metropolitan Eye Research and Surgery Institute
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Bergstrom Eye Research
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Oregon Retina, LLP
  • Texas
    • Dallas, Texas, United States, 75231
      • Texas Retina Associates
    • Houston, Texas, United States, 77030
      • Retina Consultants of Houston
    • San Antonio, Texas, United States, 78240
      • Retina and Uveitis Consultants of Texas
    • The Woodlands, Texas, United States, 77384
      • Retina Consultants of Houston
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Eye Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of ADX-102 on anterior chamber flare using an anterior uveitis grading scale.	Evaluate the signs and symptoms of ADX-102 Ophthalmic Solution on anterior chamber flare in subjects with non-infectious anterior uveitis.	Efficacy assessment period (Day 1 through Day 29)

Collaborators and Investigators

• Sponsor: Aldeyra Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2017
• Primary Completion (Actual): April 19, 2019
• Study Completion (Actual): April 26, 2019

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: reproxalap
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Panuveitis; Iris Diseases; Uveitis; Uveitis, Anterior; Iridocyclitis; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: ADX-102-UV-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No