Back to resultsA Phase 4 Study Investigating the Efficacy of Retaine™ in Managing Signs and Symptoms Associated With Dry Eye Syndrome
Primary Purpose
Keratoconjunctivitis Sicca
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Retaine™
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconjunctivitis Sicca focused on measuring Dry Eye, Dry Eye Syndrome, Retaine, KCS, Keratoconjunctivitis sicca
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Retain 1-2 drops, bilaterally, BID
Outcomes
Primary Outcome Measures
Tear Film Break-Up Time
Ocular surface damage as measured by fluorescein staining
Secondary Outcome Measures
Full Information
NCT ID
NCT02139033
First Posted
May 6, 2014
Last Updated
June 10, 2014
Sponsor
Ocusoft, Inc.
Collaborators
ORA, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02139033
Brief Title
A Phase 4 Study Investigating the Efficacy of Retaine™ in Managing Signs and Symptoms Associated With Dry Eye Syndrome
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 Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocusoft, Inc.
Collaborators
ORA, Inc.
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the efficacy of Retaine™ ophthalmic emulsion in treating the signs and symptoms of dry eye syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconjunctivitis Sicca
Keywords
Dry Eye, Dry Eye Syndrome, Retaine, KCS, Keratoconjunctivitis sicca
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Retain 1-2 drops, bilaterally, BID
Intervention Type
Drug
Intervention Name(s)
Retaine™
Primary Outcome Measure Information:
Title
Tear Film Break-Up Time
Time Frame
Day 15
Title
Ocular surface damage as measured by fluorescein staining
Time Frame
Day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 4 Study Investigating the Efficacy of Retaine™ in Managing Signs and Symptoms Associated With Dry Eye Syndrome
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