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

NCT02040623 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2016-10-10

Study results available
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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.

Conditions

  • Chronic Graft-versus-host Disease

Interventions

DRUG

R348 Ophthalmic Solution, 0.2%

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

DRUG

R348 Ophthalmic Solution, 0.5%

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

OTHER

Placebo Ophthalmic Solution

Placebo Ophthalmic Solution 2 drops per eye twice a day

Sponsors & Collaborators

  • Rigel Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Rigel Pharmaceuticals, Inc. · Rigel Pharmaceuticals,Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02040623 on ClinicalTrials.gov