Expired Study
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Rochester, New York 14642


Purpose:

This study will evaluate ocular surface lubricants in subjects with dry eye syndrome.


Study summary:

This study will objectively evaluate ocular surface lubricants in subjects with dry eye syndrome. Lubricants contain compounds that are purported to improve dry eye symptoms, although objective data is not available. The investigators seek to objectively evaluate the effectiveness of two lubricants and compare the results to a saline eye drop (control). The investigators will assess the lipid layer before and after the administration of three products in the same eye of 25 dry eye subjects using the ellipsometry, imaging in a "normal" environment. Subsequently the investigators will change the environment to one that causes the subjects' ocular surface to experience "evaporative stress" (warmer, less humid and greater air flow) and perform the before and after drop administration measurements with the same three products in the same eye as the first environment.


Criteria:

Inclusion Criteria: - Age 30-75 years - Good general health - Willing to spend time for the study; approximately one hour for a screening visit and 90 minutes for each of the measurement visits - Currently using an OTC artificial tear for ocular comfort, at least occasionally. - At least one positive dry eye symptom. Exclusion Criteria: - Current eye disease, infection or inflammation that requires the use of any prescription ocular medication. - Recent past eye surgery. - Female subjects may not be pregnant or lactating. - Infectious diseases


Study is Available At:


Original ID:

35809


NCT ID:

NCT01375582


Secondary ID:


Study Acronym:


Brief Title:

Objective Evaluation of Ocular Surface Lubricants in Two Environments


Official Title:

Objective Evaluation of Ocular Surface Lubricants


Overall Status:

Completed


Study Phase:

Phase 0


Genders:

Both


Minimum Age:

30 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Rochester


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Intervent


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Actual


Overall Contact Information

Official Name:James V Aquavella, MD
Principal Investigator
University of Rochester

Study Dates

Start Date:June 2011
Completion Date:June 2012
Completion Type:Actual
Primary Completion Date:June 2012
Primary Completion Type:Actual
Verification Date:December 2013
Last Changed Date:December 13, 2013
First Received Date:June 14, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Tear Film Properties
Time Frame:Measurements: There is no time restriction between the screening and 1st measurement. 6 measurement
Safety Issues:False
Description:The wavefront sensor instrument measures the eye's ability to create a sharp image. Ellipsometer (E) data identifies changes in lipid thickness and refractive index over the cornea. A thermal (T) imaging system provides thermal maps of the subject's eye

Study Interventions

Intervention Type:Drug
Name:B & L Soothe Lubricant Eye Drops
Description:Eye Drop
Arm Name:Drop Administration
Intervention Type:Drug
Name:Liposic EDO
Description:Eye Drop
Arm Name:Drop Administration
Intervention Type:Drug
Name:OcuFresh Eye Wash
Description:Saline drop
Arm Name:Drop Administration

Study Arms

Study Arm Type:Experimental
Arm Name:Drop Administration

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Rochester
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Bausch & Lomb Incorporated

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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