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

Phase 2

Completed

Interventions: Drug: R348 Ophthalmic Solution, 0.5%
Drug: Placebo
Drug: R348 Ophthalmic Solution, 0.2%

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
R348 Ophthalmic Solution, 0.5%	R348 Ophthalmic Solution, 0.5%	R348 Ophthalmic Solution, 0.5%
Placebo	Placebo	Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.
R348 Ophthalmic Solution, 0.2%	R348 Ophthalmic Solution, 0.2%	R348 Ophthalmic Solution, 0.2%

Primary Outcome Measures

Name	Time	Method
Change of Corneal Fluorescein Staining of the Inferior Cornea Region.	Baseline to Week 12	Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea.

Secondary Outcome Measures

Name	Time	Method

Locations (20): 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
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Sall Research Medical Center
🇺🇸Artesia, California, United States