To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca
DROPS
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
1 other identifier
interventional
204
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2013
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 11, 2013
CompletedFirst Posted
Study publicly available on registry
July 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
October 3, 2016
CompletedOctober 3, 2016
August 1, 2016
1 year
July 11, 2013
June 6, 2016
August 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline to Week 12
Study Arms (3)
R348 Ophthalmic Solution, 0.2%
ACTIVE COMPARATORR348 Ophthalmic Solution, 0.2%
R348 Ophthalmic Solution, 0.5%
ACTIVE COMPARATORR348 Ophthalmic Solution, 0.5%
Placebo
PLACEBO COMPARATORPlacebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.
Interventions
R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks.
R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Sall Research Medical Center
Artesia, California, 90701, United States
North Bay Eye
Petaluma, California, 94954, United States
Martel Medical Eye Group
Rancho Cardova, California, 95670, United States
Specialty Eye Care
Parker, Colorado, 808134, United States
International Research Center
Brandon, Florida, 33603, United States
East Florida Eye Institute
Stuart, Florida, 34994, United States
Clayton Eye Center
Morrow, Georgia, 30260, United States
Coastal Research Associates
Roswell, Georgia, 30076, United States
Chicago Research Center
Chicago, Illinois, 60634, United States
Chicago Cornea Consultants
Hoffman Estates, Illinois, 60169, United States
Koffler Vision Group
Lebanon, Kentucky, 40033, United States
Taustine Eye Center
Louisville, Kentucky, 40217, United States
Comprehensive Eye Care, Ltd/Vision Research Institute, LLC
Washington, Missouri, 63090, United States
Mundorf Eye Center
Charlotte, North Carolina, 28204, United States
Charlotte Eye Ear Nose and Throat Associates, PA
Charlotte, North Carolina, 28210, United States
Cornerstone Eyecare
High Point, North Carolina, 27262, United States
Abrams Eye Center
Cleveland, Ohio, 44115, United States
Glaucoma Consultants and Center for Eye Research
Mt. Pleasant, South Carolina, 29464, United States
Chattanooga Eye Institute
Chattanooga, Tennessee, 37411, United States
Eye Clinics of South Texas
San Antonio, Texas, 78209, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anne-Marie Duliege, MD
- Organization
- Rigel
Study Officials
- STUDY DIRECTOR
Daniel Magilavy, MD
Rigel Pharmaceuticals,Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2013
First Posted
July 16, 2013
Study Start
July 1, 2013
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
October 3, 2016
Results First Posted
October 3, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share