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

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Mild to moderate Keratoconjunctivitis Sicca.

• A corrected visual acuity in both eyes of 20/40 or better.

• An intraocular pressure of < 21 mm Hg with a difference between eyes of < 6 mm Hg.

Exclusion Criteria:

• History or evidence of ocular infection, inflammation, or conjunctivitis within 2 months prior to the first dosing day.

• History or evidence of blepharitis requiring the use of antibiotics or eye scrubs within 2 months prior to the first dosing day.

• History of herpes simplex keratitis at any time.

• Current ocular allergy symptoms.

• Recent use of eye medications such as steroids or cyclosporine

• Refractive eye surgery within 12 months of the first dosing day.

• Other eye surgeries within 4 months of the first dosing day.

• Current use of contact lenses or discontinuation of contact lens use within 2 weeks of the first dosing day.

• Receipt of any blood or blood products within 90 days prior to the first dosing day.

• Participation in any clinical study within 30 days prior to the first dosing day.

• History of disease, or currently have a significant illness or abnormal laboratory finding as determined by your study doctor.

• Positive for hepatitis B, hepatitis C or HIV.

• Smoked regularly within 12 months of first dosing day.

• History of substance abuse, drug addiction or alcoholism.