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Completed

NCT Number: NCT01483989

In Vivo Measurement of Corneal Epithelial Changes in Dry Eye Patients

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

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must have history of dry eye as determined by:

  • Questionnaire
  • Tear Film Break Up Time less than or equal to 10 seconds
  • Schirmer's score of less than or equal to 5 mm
  • Corneal staining greater than or equal to 3 in either eye, and
  • 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.

Treatment and study plan

SYSTANE® Gel Drop lubricant eye gel

Other

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

Other names: Systane Gel

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 2, 2011
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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