Clinical trial NCT03131154: SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-infectious Anterior Uveitis
Keywords: reproxalap
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-27
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells
timeFrame: The efficacy assessment period was 4 weeks; baseline was defined as Day 1.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Department of Ophthalmology
state: Alabama
city: Phoenix
country: United States
facility: Retinal Research Institute
state: Arizona
city: Prescott
country: United States
facility: M&M Eye Institute
state: Arizona
city: Sun City
country: United States
facility: Walman Eye Center
state: Arizona
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Palo Alto
country: United States
facility: Byers Eye Institute at Stanford University
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group, Inc.
state: California
city: Littleton
country: United States
facility: Corneal Consultants of Colorado
state: Colorado
city: Danbury
country: United States
facility: Danbury Eye Physicians & Surgeons
state: Connecticut
city: Jacksonville
country: United States
facility: Levenson Eye Associates
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Baltimore
country: United States
facility: John Hopkins
state: Maryland
city: Ayer
country: United States
facility: Valley Eye Physicians & Surgeons
state: Massachusetts
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Waltham
country: United States
facility: Ocular Immunology & Uveitis Foundation
state: Massachusetts
city: Birmingham
country: United States
facility: Oakland Ophthalmic Surgery
state: Michigan
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: Palisades Park
country: United States
facility: Metropolitan Eye Research and Surgery Institute
state: New Jersey
city: Fargo
country: United States
facility: Bergstrom Eye Research
state: North Dakota
city: Eugene
country: United States
facility: Oregon Retina, LLP
state: Oregon
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
city: San Antonio
country: United States
facility: Retina and Uveitis Consultants of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
References: