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

Keratoconjunctivitis Sicca Clinical Trial

Official title:

A Single-Center Evaluation of Retaine™ Ophthalmic Emulsion in the Management of Tear Film Stability and Ocular Surface Staining in Patients Diagnosed With Dry Eye

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139033
• Other study ID #: 13-110-0008
• Status: Completed
• Phase: Phase 4
• First received: May 6, 2014
• Last updated: June 10, 2014
• Start date: May 2014
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Ocusoft, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy of Retaine™ ophthalmic emulsion in treating the signs and symptoms of dry eye syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Retaine™

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ocusoft, Inc.	ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear Film Break-Up Time		Day 15	No
Primary	Ocular surface damage as measured by fluorescein staining		Day 15	No