NCT01733992

A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease

A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Pharmacokinetics, Tolerability and Safety Study of R932348 Ophthalmic Solution in Patients With Mild to Moderate Keratoconjunctivitis Sicca

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Rigel Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of R348 eye drops in patients with dry eye disease.

Detailed description

This is a randomized, double-blind, placebo-controlled single and multiple ascending dose study to evaluate the ocular tolerability, safety, and pharmacokinetics of R348 administered in patients with mild to moderate keratoconjunctivitis sicca (KCS).

Conditions

• Keratoconjunctivitis Sicca

Interventions

Type	Name	Description
DRUG	R348 Ophthalmic Solution, 0.2%	R348 Ophthalmic Solution, 0.2% single and multiple ascending dose
DRUG	R348 Ophthalmic Solution, 0.5%	R348 Ophthalmic Solution, 0.5%, single and multiple ascending dose
DRUG	R348 Ophthalmic Solution, 1.0%	R348 Ophthalmic Solution, 1.0%, single and multiple ascending dose
DRUG	Placebo	Placebo, single and multiple ascending dose

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-11-27
• Last updated: 2014-08-04

Locations

1 site across 1 country: United States