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Objective Evaluation of Ocular Surface Lubricants in Two Environments

Primary Purpose

Dry Eye

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

B & L Soothe Lubricant Eye Drops

Liposic EDO

OcuFresh Eye Wash

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring Dry Eye, tear film, lipid, tear volume, environmental chamber, thermal imaging

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Flaum Eye Institute at the University of Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Drop Administration

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01375582

First Posted

June 14, 2011

Last Updated

November 19, 2022

Sponsor

University of Rochester

Collaborators

Bausch & Lomb Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01375582

Brief Title

Objective Evaluation of Ocular Surface Lubricants in Two Environments

Official Title

Objective Evaluation of Ocular Surface Lubricants

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

Collaborators

Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

Keywords

Dry Eye, tear film, lipid, tear volume, environmental chamber, thermal imaging

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare Provider

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Drop Administration

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

B & L Soothe Lubricant Eye Drops

Intervention Description

Eye Drop

Intervention Type

Drug

Intervention Name(s)

Liposic EDO

Intervention Description

Eye Drop

Intervention Type

Drug

Intervention Name(s)

OcuFresh Eye Wash

Intervention Description

Saline drop

Primary Outcome Measure Information:

Title

Tear Film Properties

Description

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James V Aquavella, MD

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

Flaum Eye Institute at the University of Rochester

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Objective Evaluation of Ocular Surface Lubricants in Two Environments

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