Safety and Efficacy Study of R932348 Ophthalmic Solution in Chronic Ocular Graft Versus Host Disease Patients(DROPS-2)

* 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.

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Key information

Conditions

Chronic Graft-versus-host Disease Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Conjunctival Diseases Conjunctivitis Corneal Diseases Dry Eye Syndromes Eye Diseases Graft vs Host Disease Immune System Diseases Keratitis Keratoconjunctivitis Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

U. Miami - Bascom Palmer Eye Institute, Plantation, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

R348 Ophthalmic Solution, 0.2%

Drug

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

Other names: R932348

R348 Ophthalmic Solution, 0.5%

Drug

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

Other names: R932348

Placebo Ophthalmic Solution

Other

Placebo Ophthalmic Solution 2 drops per eye twice a day

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.

Sponsors and collaborators

Lead sponsor

Rigel Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: DROPS-2

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Jan 20, 2014
Registry last updated: Oct 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed