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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Rigel Pharmaceuticals
- Enrollment
- 204
- Locations
- 20
- Primary Endpoint
- Change of Corneal Fluorescein Staining of the Inferior Cornea Region.
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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%
R348 Ophthalmic Solution, 0.2%
Intervention: R348 Ophthalmic Solution, 0.2% (Drug)
R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5%
Intervention: R348 Ophthalmic Solution, 0.5% (Drug)
Placebo
Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.
Intervention: Placebo (Drug)
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.
Secondary Outcomes
No secondary outcomes reported