NCT01900249

To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca

A 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 in Patients With Keratoconjunctivitis Sicca

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Rigel Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.

Conditions

• Keratoconjunctivitis Sicca

Interventions

Type	Name	Description
DRUG	R348 Ophthalmic Solution, 0.2%	R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks.
DRUG	R348 Ophthalmic Solution, 0.5%	R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.
DRUG	Placebo	Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2013-07-16
• Last updated: 2016-10-03
• Results posted: 2016-10-03

Locations

20 sites across 1 country: United States