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

NCT02139033 | Completed Phase 4

• 1 other identifier: 13-110-0008
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Keratoconjunctivitis Sicca

Keywords

Dry Eye, Dry Eye Syndrome, Retaine, KCS, Keratoconjunctivitis sicca

Outcome Measures

Primary Outcomes (2)

• Tear Film Break-Up Time

  Day 15

• Ocular surface damage as measured by fluorescein staining

  Day 15

Study Arms (1)

Arm 1

EXPERIMENTAL

Retain 1-2 drops, bilaterally, BID

Drug: Retaine™

Interventions

Retaine™ DRUG

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ocusoft, Inc.: lead
• ORA, Inc.: collaborator

Study Sites (1)

Unknown Facility

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Keratoconjunctivitis Sicca; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 15, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 11, 2014

Record last verified: 2014-06

Locations

US (1)