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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigel Pharmaceuticals
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• A history of dry eye (based on the date of initial dry eye symptoms)

• Use of over-the-counter (OTC) and/or prescription eye drops for dry eye symptoms

• Corneal fluorescein staining score of at least 2 in the inferior region

Exclusion Criteria:

• History of, or a concurrent clinically significant illness, medical condition (other than Keratoconjunctivitis Sicca or Sjögren's syndrome), or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study.

• Use of ophthalmic cyclosporine within 45 days of Visit 1.

• Use of any topical ophthalmic steroid within 2 weeks of Visit 1.

• Have worn contact lenses or anticipate using contact lenses during the study.

• Have a condition or be in a situation that the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

• Have a history of alcohol or substance abuse that, in the judgment of the Investigator, may impair or risk the subject's full participation in the study.