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

Completed · Phase 2 · Has a placebo group

Conditions studied: Keratoconjunctivitis Sicca

In brief

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.

Key facts

Study ID

NCT01900249

Run by

Rigel Pharmaceuticals

People needed

204

Starts

2013-07-01

Expected to finish

2014-07-01

Last updated by the study team

2016-10-03

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Sall Research Medical Center — Artesia, California, United States
• North Bay Eye — Petaluma, California, United States
• Martel Medical Eye Group — Rancho Cardova, California, United States
• Specialty Eye Care — Parker, Colorado, United States
• International Research Center — Brandon, Florida, United States
• East Florida Eye Institute — Stuart, Florida, United States
• Clayton Eye Center — Morrow, Georgia, United States
• Coastal Research Associates — Roswell, Georgia, United States
• Chicago Research Center — Chicago, Illinois, United States
• Chicago Cornea Consultants — Hoffman Estates, Illinois, United States
• Koffler Vision Group — Lebanon, Kentucky, United States
• Taustine Eye Center — Louisville, Kentucky, United States
• Comprehensive Eye Care, Ltd/Vision Research Institute, LLC — Washington, Missouri, United States
• Mundorf Eye Center — Charlotte, North Carolina, United States
• Charlotte Eye Ear Nose and Throat Associates, PA — Charlotte, North Carolina, United States
• Cornerstone Eyecare — High Point, North Carolina, United States
• Abrams Eye Center — Cleveland, Ohio, United States
• Glaucoma Consultants and Center for Eye Research — Mt. Pleasant, South Carolina, United States
• Chattanooga Eye Institute — Chattanooga, Tennessee, United States
• Eye Clinics of South Texas — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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