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

Phase 3

Completed

• Conditions: Non-infectious Anterior Uveitis
• Interventions: Drug: ADX-102 Ophthalmic Solution (0.5%); Drug: Vehicle of ADX-102 Ophthalmic Solution

• Registration Number: NCT03131154
• Lead Sponsor: Aldeyra Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-24
• Study Start: 2017-04-26
• Study First Posted: 2017-04-27
• Primary Completion: 2019-04-19
• Study Completion: 2019-04-26
• Status Verified: 2020-05
• Disposition First Submitted: 2020-05-11
• Results First Submitted: 2023-02-16
• Results First Submitted QC: 2025-01-17
• Last Update Submitted: 2025-01-17
• Results First Posted: 2025-02-10
• Disposition First Posted: 2025-02-10
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADX-102 Ophthalmic Solution (0.5%)	ADX-102 Ophthalmic Solution (0.5%)	-
Vehicle of ADX-102 Ophthalmic Solution	Vehicle of ADX-102 Ophthalmic Solution	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells	The efficacy assessment period was 4 weeks; baseline was defined as Day 1.	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).

Trial Locations

Locations (26)

UAB Department of Ophthalmology; 🇺🇸 Birmingham, Alabama, United States

Retinal Research Institute; 🇺🇸 Phoenix, Arizona, United States

M&M Eye Institute; 🇺🇸 Prescott, Arizona, United States

Walman Eye Center; 🇺🇸 Sun City, Arizona, United States

Retina-Vitreous Associates Medical Group; 🇺🇸 Beverly Hills, California, United States

University of California, Irvine; 🇺🇸 Irvine, California, United States

Byers Eye Institute at Stanford University; 🇺🇸 Palo Alto, California, United States

Retinal Consultants Medical Group, Inc.; 🇺🇸 Sacramento, California, United States

Corneal Consultants of Colorado; 🇺🇸 Littleton, Colorado, United States

Danbury Eye Physicians & Surgeons; 🇺🇸 Danbury, Connecticut, United States

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