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

NCT ID: NCT03131154

Last Updated: 2025-02-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-26

Study Completion Date

2019-04-26

Brief Summary

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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.

Detailed Description

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Conditions

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Non-infectious Anterior Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ADX-102 Ophthalmic Solution (0.5%)

Group Type EXPERIMENTAL

ADX-102 Ophthalmic Solution (0.5%)

Intervention Type DRUG

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

Vehicle of ADX-102 Ophthalmic Solution

Group Type PLACEBO_COMPARATOR

Vehicle of ADX-102 Ophthalmic Solution

Intervention Type DRUG

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

Interventions

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ADX-102 Ophthalmic Solution (0.5%)

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

Intervention Type DRUG

Vehicle of ADX-102 Ophthalmic Solution

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

Intervention Type DRUG

Other Intervention Names

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Reproxalap Vehicle of Reproxlap

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aldeyra Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UAB Department of Ophthalmology

Birmingham, Alabama, United States

Site Status

Retinal Research Institute

Phoenix, Arizona, United States

Site Status

M&M Eye Institute

Prescott, Arizona, United States

Site Status

Walman Eye Center

Sun City, Arizona, United States

Site Status

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Site Status

University of California, Irvine

Irvine, California, United States

Site Status

Byers Eye Institute at Stanford University

Palo Alto, California, United States

Site Status

Retinal Consultants Medical Group, Inc.

Sacramento, California, United States

Site Status

Corneal Consultants of Colorado

Littleton, Colorado, United States

Site Status

Danbury Eye Physicians & Surgeons

Danbury, Connecticut, United States

Site Status

Levenson Eye Associates

Jacksonville, Florida, United States

Site Status

Center for Retina and Macular Disease

Winter Haven, Florida, United States

Site Status

Midwest Eye Institute

Indianapolis, Indiana, United States

Site Status

John Hopkins

Baltimore, Maryland, United States

Site Status

Valley Eye Physicians & Surgeons

Ayer, Massachusetts, United States

Site Status

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status

Ocular Immunology & Uveitis Foundation

Waltham, Massachusetts, United States

Site Status

Oakland Ophthalmic Surgery

Birmingham, Michigan, United States

Site Status

Tauber Eye Center

Kansas City, Missouri, United States

Site Status

Metropolitan Eye Research and Surgery Institute

Palisades Park, New Jersey, United States

Site Status

Bergstrom Eye Research

Fargo, North Dakota, United States

Site Status

Oregon Retina, LLP

Eugene, Oregon, United States

Site Status

Texas Retina Associates

Dallas, Texas, United States

Site Status

Retina Consultants of Houston

Houston, Texas, United States

Site Status

Retina and Uveitis Consultants of Texas

San Antonio, Texas, United States

Site Status

Retina Consultants of Houston

The Woodlands, Texas, United States

Site Status

Virginia Eye Consultants

Norfolk, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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ADX-102-UV-005

Identifier Type: -

Identifier Source: org_study_id

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