Status:
COMPLETED
To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca
Lead Sponsor:
Rigel Pharmaceuticals
Conditions:
Keratoconjunctivitis Sicca
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT01900249
Start Date
July 1 2013
End Date
July 1 2014
Last Update
October 3 2016
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
Sall Research Medical Center
Artesia, California, United States, 90701
2
North Bay Eye
Petaluma, California, United States, 94954
3
Martel Medical Eye Group
Rancho Cardova, California, United States, 95670
4
Specialty Eye Care
Parker, Colorado, United States, 808134