In Vivo Measurement of Corneal Epithelial Changes in Dry Eye Patients

November 17, 2016 updated by: Alcon Research

In Vivo Measurement of Corneal Epithelial Changes in Dry Eye(DE) Patients

The purpose of this study is to measure corneal epithelial changes in dry eye subjects using a novel lubricant eye gel.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to measure corneal epithelial changes in dry eye (DE) subjects using a novel lubricant eye gel.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects must have history of dry eye as determined by:

  1. Questionnaire
  2. Tear Film Break Up Time less than or equal to 10 seconds
  3. Schirmer's score of less than or equal to 5 mm
  4. Corneal staining greater than or equal to 3 in either eye, and
  5. Positive for conjunctival staining (greater than or equal to 1)

Exclusion Criteria:

  • Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Gel Drops.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SYSTANE® Gel Drops Lubricant eye gel
SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period.
Other: SYSTANE® Gel Drop lubricant eye gel
SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period.
Other Names:
  • Systane Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.
Time Frame: baseline and 28 days
The Changes in epithelial irregularity following 4 weeks of treatment with a novel artificial tear gel.
baseline and 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • http://iovs.arvojournals.org/article.aspx?articleid=2351788

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

November 29, 2011

First Submitted That Met QC Criteria

November 30, 2011

First Posted (ESTIMATE)

December 2, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 17, 2016

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMA-09-49

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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