NCT03131154

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Aldeyra Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-infectious Anterior Uveitis

Interventions

Type	Name	Description
DRUG	ADX-102 Ophthalmic Solution (0.5%)	ADX-102 Ophthalmic Solution (0.5%) administered for approximately four weeks.
DRUG	Vehicle of ADX-102 Ophthalmic Solution	Vehicle of ADX-102 Ophthalmic Solution administered for approximately four weeks.

Timeline

• Start date: 2017-04-26
• Primary completion: 2019-04-19
• Completion: 2019-04-26
• First posted: 2017-04-27
• Last updated: 2025-02-10
• Results posted: 2025-02-10

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated drug study