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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02139033
Other study ID # 13-110-0008
Secondary ID
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


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
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