Objective Evaluation of Ocular Surface Lubricants in Two Environments

Dry Eye Clinical Trial

Official title:

Objective Evaluation of Ocular Surface Lubricants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01375582
• Other study ID #: 35809
• Status: Completed
• Phase: Early Phase 1
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: November 2022
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes

Intervention

Drug:
• B & L Soothe Lubricant Eye Drops
Eye Drop
• Liposic EDO
Eye Drop
• OcuFresh Eye Wash
Saline drop

Locations

Country	Name	City	State
United States	Flaum Eye Institute at the University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear Film Properties	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 eyes and face adjacent to the eyes.; A questionnaire (Q) will ask subjects about their test eye's comfort. Subjects will be asked the questions prior to instillation of the eye drop and after each set of measurements.	Measurements: There is no time restriction between the screening and 1st measurement. 6 measurement visits occur approximately 7 days apart but can range from 3 to 14 days. The time between visit 3 and 4 are not be closer than 3 days, but no upper limit.