Clinical trial NCT01900249: To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca
Official title: A Phase 2, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.2% and 0.5% R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Keratoconjunctivitis Sicca
Lead sponsor: Rigel Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-07-16
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change of Corneal Fluorescein Staining of the Inferior Cornea Region.
timeFrame: Baseline to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: Petaluma
country: United States
facility: North Bay Eye
state: California
city: Rancho Cardova
country: United States
facility: Martel Medical Eye Group
state: California
city: Parker
country: United States
facility: Specialty Eye Care
state: Colorado
city: Brandon
country: United States
facility: International Research Center
state: Florida
city: Stuart
country: United States
facility: East Florida Eye Institute
state: Florida
city: Morrow
country: United States
facility: Clayton Eye Center
state: Georgia
city: Roswell
country: United States
facility: Coastal Research Associates
state: Georgia
city: Chicago
country: United States
facility: Chicago Research Center
state: Illinois
city: Hoffman Estates
country: United States
facility: Chicago Cornea Consultants
state: Illinois
city: Lebanon
country: United States
facility: Koffler Vision Group
state: Kentucky
city: Louisville
country: United States
facility: Taustine Eye Center
state: Kentucky
city: Washington
country: United States
facility: Comprehensive Eye Care, Ltd/Vision Research Institute, LLC
state: Missouri
city: Charlotte
country: United States
facility: Mundorf Eye Center
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose and Throat Associates, PA
state: North Carolina
city: High Point
country: United States
facility: Cornerstone Eyecare
state: North Carolina
city: Cleveland
country: United States
facility: Abrams Eye Center
state: Ohio
city: Mt. Pleasant
country: United States
facility: Glaucoma Consultants and Center for Eye Research
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Eye Institute
state: Tennessee
city: San Antonio
country: United States
facility: Eye Clinics of South Texas
state: Texas
Study officials:
affiliation: Rigel Pharmaceuticals,Inc.
name: Daniel Magilavy, MD
role: STUDY_DIRECTOR
References: