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

Keratoconjunctivitis Sicca Clinical Trial

— DROPS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01900249
• Other study ID #: C-932348-003
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2013
• Last updated: July 11, 2014
• Start date: July 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Rigel Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Drug:
• R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks.
• R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.
• Placebo
Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Rigel Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of inferior corneal fluorescein staining score.		Baseline to Week 12	Yes