search
Back to results

To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca (DROPS)

Primary Purpose

Keratoconjunctivitis Sicca

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

About this trial

This is an interventional treatment trial for Keratoconjunctivitis Sicca

Eligibility Criteria

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

Inclusion Criteria:

  • A history of dry eye (based on the date of initial dry eye symptoms)
  • Use of over-the-counter (OTC) and/or prescription eye drops for dry eye symptoms
  • Corneal fluorescein staining score of at least 2 in the inferior region

Exclusion Criteria:

  • History of, or a concurrent clinically significant illness, medical condition (other than Keratoconjunctivitis Sicca or Sjögren's syndrome), or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study.
  • Use of ophthalmic cyclosporine within 45 days of Visit 1.
  • Use of any topical ophthalmic steroid within 2 weeks of Visit 1.
  • Have worn contact lenses or anticipate using contact lenses during the study.
  • Have a condition or be in a situation that the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
  • Have a history of alcohol or substance abuse that, in the judgment of the Investigator, may impair or risk the subject's full participation in the study.

Sites / Locations

  • Sall Research Medical Center
  • North Bay Eye
  • Martel Medical Eye Group
  • Specialty Eye Care
  • International Research Center
  • East Florida Eye Institute
  • Clayton Eye Center
  • Coastal Research Associates
  • Chicago Research Center
  • Chicago Cornea Consultants
  • Koffler Vision Group
  • Taustine Eye Center
  • Comprehensive Eye Care, Ltd/Vision Research Institute, LLC
  • Mundorf Eye Center
  • Charlotte Eye Ear Nose and Throat Associates, PA
  • Cornerstone Eyecare
  • Abrams Eye Center
  • Glaucoma Consultants and Center for Eye Research
  • Chattanooga Eye Institute
  • Eye Clinics of South Texas

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%

R348 Ophthalmic Solution, 0.5%

Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.

Outcomes

Primary Outcome Measures

Change of Corneal Fluorescein Staining of the Inferior Cornea Region.
Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea.

Secondary Outcome Measures

Full Information

First Posted
July 11, 2013
Last Updated
August 9, 2016
Sponsor
Rigel Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT01900249
Brief Title
To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca
Acronym
DROPS
Official Title
A 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 in Patients With Keratoconjunctivitis Sicca
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (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
The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconjunctivitis Sicca

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R348 Ophthalmic Solution, 0.2%
Arm Type
Active Comparator
Arm Description
R348 Ophthalmic Solution, 0.2%
Arm Title
R348 Ophthalmic Solution, 0.5%
Arm Type
Active Comparator
Arm Description
R348 Ophthalmic Solution, 0.5%
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
R348 Ophthalmic Solution, 0.2%
Other Intervention Name(s)
R932348
Intervention Description
R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
R348 Ophthalmic Solution, 0.5%
Other Intervention Name(s)
R932348
Intervention Description
R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.
Primary Outcome Measure Information:
Title
Change of Corneal Fluorescein Staining of the Inferior Cornea Region.
Description
Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea.
Time Frame
Baseline to Week 12

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: A history of dry eye (based on the date of initial dry eye symptoms) Use of over-the-counter (OTC) and/or prescription eye drops for dry eye symptoms Corneal fluorescein staining score of at least 2 in the inferior region Exclusion Criteria: History of, or a concurrent clinically significant illness, medical condition (other than Keratoconjunctivitis Sicca or Sjögren's syndrome), or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study. Use of ophthalmic cyclosporine within 45 days of Visit 1. Use of any topical ophthalmic steroid within 2 weeks of Visit 1. Have worn contact lenses or anticipate using contact lenses during the study. Have a condition or be in a situation that the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study. Have a history of alcohol or substance abuse that, in the judgment of the Investigator, may impair or risk the subject's full participation in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Magilavy, MD
Organizational Affiliation
Rigel Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Sall Research Medical Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
North Bay Eye
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Martel Medical Eye Group
City
Rancho Cardova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Specialty Eye Care
City
Parker
State/Province
Colorado
ZIP/Postal Code
808134
Country
United States
Facility Name
International Research Center
City
Brandon
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
East Florida Eye Institute
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
Facility Name
Clayton Eye Center
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Coastal Research Associates
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Chicago Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Facility Name
Chicago Cornea Consultants
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Koffler Vision Group
City
Lebanon
State/Province
Kentucky
ZIP/Postal Code
40033
Country
United States
Facility Name
Taustine Eye Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Comprehensive Eye Care, Ltd/Vision Research Institute, LLC
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Mundorf Eye Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Charlotte Eye Ear Nose and Throat Associates, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Cornerstone Eyecare
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Abrams Eye Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
Glaucoma Consultants and Center for Eye Research
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Chattanooga Eye Institute
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
Eye Clinics of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca

We'll reach out to this number within 24 hrs