A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease
Completed · Phase 1 · Has a placebo group
Conditions studied: Keratoconjunctivitis Sicca
In brief
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of R348 eye drops in patients with dry eye disease.
Key facts
- Study ID
- NCT01733992
- Run by
- Rigel Pharmaceuticals
- People needed
- 36
- Starts
- 2012-11-01
- Expected to finish
- 2013-02-01
- Last updated by the study team
- 2014-08-04
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Andover Eye Associates — Andover, Massachusetts, United States
Full record on ClinicalTrials.gov
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