Keratoconjunctivitis Sicca
Conditions
Keywords
Dry Eye, Dry Eye Syndrome, Retaine, KCS, Keratoconjunctivitis sicca
Brief summary
This study will evaluate the efficacy of Retaine™ ophthalmic emulsion in treating the signs and symptoms of dry eye syndrome.
Interventions
DRUGRetaine™
Sponsors
ORA, Inc.
Ocusoft, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years of age; * Provide written informed consent; * Have a reported history of dry eye; * Have a history of use or desire to use eye drops;
Exclusion criteria
* Have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; * Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study; * Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months; * Have used Restasis® within 30 days of Visit 1; * Be a woman who is pregnant, nursing or planning a pregnancy; * Be unwilling to submit a urine pregnancy test if of childbearing potential; * Have a known allergy and/or sensitivity to the test article or its components; * Have a condition or be in a situation which 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; * Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tear Film Break-Up Time | Day 15 |
| Ocular surface damage as measured by fluorescein staining | Day 15 |
Countries
United States
Outcome results
None listed