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

Rigel Pharmaceuticals20 sites in 1 country204 target enrollmentJuly 2013

ConditionsKeratoconjunctivitis Sicca

InterventionsR348 Ophthalmic Solution, 0.2%R348 Ophthalmic Solution, 0.5%Placebo

DrugsR348 Ophthalmic Solution, 0.2%R348 Ophthalmic Solution, 0.5%Placebo

Overview

Phase: Phase 2
Intervention: R348 Ophthalmic Solution, 0.2%
Conditions: Keratoconjunctivitis Sicca
Sponsor: Rigel Pharmaceuticals
Enrollment: 204
Locations: 20
Primary Endpoint: Change of Corneal Fluorescein Staining of the Inferior Cornea Region.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2013

End Date

July 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rigel Pharmaceuticals

Responsible Party

Sponsor

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
•Use of any topical ophthalmic steroid within 2 weeks of Visit
•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.

Arms & Interventions

R348 Ophthalmic Solution, 0.2%

Intervention: R348 Ophthalmic Solution, 0.2%

R348 Ophthalmic Solution, 0.5%

Intervention: R348 Ophthalmic Solution, 0.5%

Placebo

Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.

Intervention: Placebo

Outcomes

Primary Outcomes

Change of Corneal Fluorescein Staining of the Inferior Cornea Region.

Time Frame: 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.