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

August 17, 2016 updated by: Rigel Pharmaceuticals

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

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Plantation, Florida, United States, 33324
        • U. Miami - Bascom Palmer Eye Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye and Ear Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
Drug: R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
Other Names:
  • R932348
Active Comparator: R348 Ophthalmic Solution, 0.5%
R348 Ophthalmic Solution, 0.5% 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 Names:
  • R932348
Placebo Comparator: Placebo
Placebo Ophthalmic Solution 2 drops per eye twice a day
Other: Placebo Ophthalmic Solution
Placebo Ophthalmic Solution 2 drops per eye twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigel Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

January 16, 2014

First Submitted That Met QC Criteria

January 16, 2014

First Posted (Estimate)

January 20, 2014

Study Record Updates

Last Update Posted (Estimate)

October 10, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-932348-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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