A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease
Phase 1
Completed
- Conditions
- Keratoconjunctivitis Sicca
- Interventions
- Drug: R348 Ophthalmic Solution, 0.5%Drug: R348 Ophthalmic Solution, 1.0%Drug: R348 Ophthalmic Solution, 0.2%Drug: Placebo
- Registration Number
- NCT01733992
- Lead Sponsor
- Rigel Pharmaceuticals
- Brief 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description R348 Ophthalmic Solution, 0.5% R348 Ophthalmic Solution, 0.5% R348 Ophthalmic Solution, 0.5%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day. R348 Ophthalmic Solution, 1.0% R348 Ophthalmic Solution, 1.0% R348 Ophthalmic Solution, 1.0%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day. R348 Ophthalmic Solution, 0.2% R348 Ophthalmic Solution, 0.2% R348 Ophthalmic Solution, 0.2%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day. R348 Ophthalmic Solution, 0.2% Placebo R348 Ophthalmic Solution, 0.2%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day. R348 Ophthalmic Solution, 0.5% Placebo R348 Ophthalmic Solution, 0.5%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day. R348 Ophthalmic Solution, 1.0% Placebo R348 Ophthalmic Solution, 1.0%, single (1 day) and multiple ascending dose (13 days) followed by a single dose on the fourteenth day. Placebo Placebo Placebo, single (1 day) or multiple ascending dose (13 days) followed by a single dose on the fourteenth day.
- Primary Outcome Measures
Name Time Method Change in corneal fluorescein staining Baseline and Visits 4, 8 and 12
- Secondary Outcome Measures
Name Time Method Change in conjunctival lissamine green staining Baseline and Visits 4, 8 and 12
Trial Locations
- Locations (1)
Andover Eye Associates
🇺🇸Andover, Massachusetts, United States