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

Non-infectious Anterior Uveitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03131154
• Other study ID #: ADX-102-UV-005
• Status: Completed
• Phase: Phase 3
• Start date: April 26, 2017
• Est. completion date: April 26, 2019

Study information

• Verified date: May 2020
• Source: Aldeyra Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: April 26, 2019
• Est. primary completion date: April 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Iridocyclitis
• Non-infectious Anterior Uveitis
• Uveitis
• Uveitis, Anterior

Intervention

Drug:
• ADX-102 Ophthalmic Solution (0.5%)
ADX-102 Ophthalmic Solution (0.5%) administered for approximately four weeks.
• Vehicle of ADX-102 Ophthalmic Solution
Vehicle of ADX-102 Ophthalmic Solution administered for approximately four weeks.

Locations

Country	Name	City	State
United States	Valley Eye Physicians & Surgeons	Ayer	Massachusetts
United States	John Hopkins	Baltimore	Maryland
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Oakland Ophthalmic Surgery	Birmingham	Michigan
United States	UAB Department of Ophthalmology	Birmingham	Alabama
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Texas Retina Associates	Dallas	Texas
United States	Danbury Eye Physicians & Surgeons	Danbury	Connecticut
United States	Oregon Retina, LLP	Eugene	Oregon
United States	Bergstrom Eye Research	Fargo	North Dakota
United States	Retina Consultants of Houston	Houston	Texas
United States	Midwest Eye Institute	Indianapolis	Indiana
United States	University of California, Irvine	Irvine	California
United States	Levenson Eye Associates	Jacksonville	Florida
United States	Tauber Eye Center	Kansas City	Missouri
United States	Corneal Consultants of Colorado	Littleton	Colorado
United States	Virginia Eye Consultants	Norfolk	Virginia
United States	Metropolitan Eye Research and Surgery Institute	Palisades Park	New Jersey
United States	Byers Eye Institute at Stanford University	Palo Alto	California
United States	Retinal Research Institute	Phoenix	Arizona
United States	M&M Eye Institute	Prescott	Arizona
United States	Retinal Consultants Medical Group, Inc.	Sacramento	California
United States	Retina and Uveitis Consultants of Texas	San Antonio	Texas
United States	Walman Eye Center	Sun City	Arizona
United States	Retina Consultants of Houston	The Woodlands	Texas
United States	Ocular Immunology & Uveitis Foundation	Waltham	Massachusetts
United States	Center for Retina and Macular Disease	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Aldeyra Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of ADX-102 on anterior chamber cell count using an anterior uveitis grading scale.	Evaluate the efficacy of ADX-102 Ophthalmic Solution on anterior chamber cell count in subjects with non-infectious anterior uveitis.	Efficacy assessment period (Day 1 through Day 29)
Secondary	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)