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 for the Treatment of Keratoconjunctivitis Sicca in Patients With Chronic Ocular Graft Versus Host Disease

Rigel Pharmaceuticals2 sites in 1 country35 target enrollmentMarch 2014

ConditionsChronic Graft-versus-host Disease

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

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

Overview

Phase: Phase 2
Intervention: R348 Ophthalmic Solution, 0.2%
Conditions: Chronic Graft-versus-host Disease
Sponsor: Rigel Pharmaceuticals
Enrollment: 35
Locations: 2
Primary Endpoint: Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To assess the efficacy of R348 Ophthalmic Solutions administered for 12 weeks to subjects evaluated by objective and subjective measures.
To investigate the safety and tolerability of R348 Ophthalmic Solutions administered for 12 weeks to subjects.

Registry

clinicaltrials.gov

Start Date

March 2014

End Date

July 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rigel Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Received an Allogeneic hematologic stem cell transplantation at least 3 months prior.
•Subjects with post Allogeneic hematologic stem cell transplantation onset or worsening of dry eye symptoms for at least 1 month prior.
•Use of over-the-counter and/or prescription eye drops for dry eye symptoms within 1 month.
•Corneal fluorescein staining score of ≥ 2 in 1 region and ≥ 1 in at least 1 other region.
•Total lissamine green conjunctival staining score (according to a modified National Eye Institute grading system) of ≥ 2.

Exclusion Criteria

•Clinically unstable Graft versus Host Disease (requiring a change in immunosuppressive regimen), medical condition, or laboratory abnormality
•Used topical ophthalmic cyclosporine within 45 days.
•Used any topical ophthalmic steroid within 2 weeks.
•Used autologous serum eye drops within 2 weeks.

Arms & Interventions

R348 Ophthalmic Solution, 0.2%

R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day

Intervention: R348 Ophthalmic Solution, 0.2%

R348 Ophthalmic Solution, 0.5%

R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day

Intervention: R348 Ophthalmic Solution, 0.5%

Placebo

Placebo Ophthalmic Solution 2 drops per eye twice a day

Intervention: Placebo Ophthalmic Solution

Outcomes

Primary Outcomes

Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks.

Time Frame: Baseline to 12 weeks

Change from baseline (Visit 1) of total CFS score at 12 weeks. Total CFS score range 0-20, where '0' represents no fluorescein staining of any region and '20' represents severe staining the entire cornea.