NCT02040623

Safety and Efficacy Study of R932348 Ophthalmic Solution in Chronic Ocular Graft Versus Host Disease Patients(DROPS-2)

Phase 2, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.2% and 0.5% R932348 Ophthalmic Solutions for the Treatment of Keratoconjunctivitis Sicca in Patients With Chronic Ocular Graft Versus Host Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Rigel Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

* To assess the efficacy of R348 Ophthalmic Solutions administered for 12 weeks to subjects evaluated by objective and subjective measures. * To investigate the safety and tolerability of R348 Ophthalmic Solutions administered for 12 weeks to subjects.

Conditions

• Chronic Graft-versus-host Disease

Interventions

Type	Name	Description
DRUG	R348 Ophthalmic Solution, 0.2%	R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
DRUG	R348 Ophthalmic Solution, 0.5%	R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
OTHER	Placebo Ophthalmic Solution	Placebo Ophthalmic Solution 2 drops per eye twice a day

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2014-01-20
• Last updated: 2016-10-10
• Results posted: 2016-10-10

Locations

2 sites across 1 country: United States