Overview

A Phase 4 Study Investigating the Efficacy of Retaine™ in Managing Signs and Symptoms Associated With Dry Eye Syndrome

Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate the efficacy of Retaine™ ophthalmic emulsion in treating the signs and symptoms of dry eye syndrome.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ocusoft, Inc.
Collaborator:
ORA, Inc.
Treatments:
Carboxymethylcellulose Sodium
Criteria
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.