To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 5/5/2014 |
Start Date: | July 2013 |
End Date: | July 2014 |
Contact: | Daniel Magilavy, MD |
Email: | DMagilavy@Rigel.com |
Phone: | 650-624-1372 |
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
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.
are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.
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.
We found this trial at
20
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials