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

Primary Purpose

Chronic Graft-versus-host Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
R348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.5%
Placebo Ophthalmic Solution
Sponsored by
Rigel Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Graft-versus-host Disease focused on measuring Chronic Graft versus Host Disease, Keratoconjunctivitis Sicca

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • U. Miami - Bascom Palmer Eye Institute
  • Massachusetts Eye and Ear Infirmary

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

R348 Ophthalmic Solution, 0.2%

R348 Ophthalmic Solution, 0.5%

Placebo

Arm Description

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

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

Placebo Ophthalmic Solution 2 drops per eye twice a day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 16, 2014
Last Updated
August 17, 2016
Sponsor
Rigel Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02040623
Brief Title
Safety and Efficacy Study of R932348 Ophthalmic Solution in Chronic Ocular Graft Versus Host Disease Patients(DROPS-2)
Acronym
DROPS-2
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rigel Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Graft-versus-host Disease
Keywords
Chronic Graft versus Host Disease, Keratoconjunctivitis Sicca

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R348 Ophthalmic Solution, 0.2%
Arm Type
Active Comparator
Arm Description
R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
Arm Title
R348 Ophthalmic Solution, 0.5%
Arm Type
Active Comparator
Arm Description
R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Ophthalmic Solution 2 drops per eye twice a day
Intervention Type
Drug
Intervention Name(s)
R348 Ophthalmic Solution, 0.2%
Other Intervention Name(s)
R932348
Intervention Description
R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
Intervention Type
Drug
Intervention Name(s)
R348 Ophthalmic Solution, 0.5%
Other Intervention Name(s)
R932348
Intervention Description
R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
Intervention Type
Other
Intervention Name(s)
Placebo Ophthalmic Solution
Intervention Description
Placebo Ophthalmic Solution 2 drops per eye twice a day
Primary Outcome Measure Information:
Title
Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks.
Description
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.
Time Frame
Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rigel Pharmaceuticals, Inc.
Organizational Affiliation
Rigel Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
U. Miami - Bascom Palmer Eye Institute
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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