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In Vivo Measurement of Corneal Epithelial Changes in Dry Eye Patients

NCT ID: NCT01483989

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-06-30

Brief Summary

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

Detailed Description

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

Conditions

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Dry Eye Syndrome

Keywords

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Dry Eye Epithelial changes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SYSTANE® Gel Drops Lubricant eye gel

SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period.

Group Type EXPERIMENTAL

SYSTANE® Gel Drop lubricant eye gel

Intervention Type OTHER

SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period.

Interventions

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SYSTANE® Gel Drop lubricant eye gel

SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period.

Intervention Type OTHER

Other Intervention Names

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Systane Gel

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

References

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

Reference Type RESULT

Other Identifiers

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SMA-09-49

Identifier Type: -

Identifier Source: org_study_id