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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02139033
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : June 11, 2014
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
Ocusoft, Inc.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
Retain 1-2 drops, bilaterally, BID
 Drug: Retaine™


Outcome Measures
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Primary Outcome Measures :
  1. Tear Film Break-Up Time [ Time Frame: Day 15 ]
  2. Ocular surface damage as measured by fluorescein staining [ Time Frame: Day 15 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139033


Locations
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United States, Massachusetts
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Ocusoft, Inc.
ORA, Inc.
More Information
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Responsible Party: Ocusoft, Inc.
ClinicalTrials.gov Identifier: NCT02139033    
Other Study ID Numbers: 13-110-0008
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: June 11, 2014
Last Verified: June 2014
Keywords provided by Ocusoft, Inc.:
Dry Eye, Dry Eye Syndrome, Retaine, KCS, Keratoconjunctivitis sicca
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
 Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases