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

• Sponsor: Ocusoft, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02139033
• Collaborator: ORA, Inc. (Industry)
• Enrollment: 42
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Keratoconjunctivitis Sicca	Drug: Retaine™	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Retain 1-2 drops, bilaterally, BID	Drug: Retaine™

Outcome Measures

Primary Outcome Measures

1. Tear Film Break-Up Time [Day 15]

2. Ocular surface damage as measured by fluorescein staining [Day 15]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Andover	Massachusetts	United States	01810

Sponsors and Collaborators

• Ocusoft, Inc.
• ORA, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ocusoft, Inc.
• ClinicalTrials.gov Identifier: NCT02139033
• Other Study ID Numbers: 13-110-0008
• First Posted: May 15, 2014
• Last Update Posted: Jun 11, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by Ocusoft, Inc.: Dry Eye, Dry Eye Syndrome, Retaine, KCS, Keratoconjunctivitis sicca
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratoconjunctivitis

Study Results

No Results Posted as of Jun 11, 2014