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Assessment of Tear Film Thickness by Optical Coherence Tomography in Healthy Subjects and Subjects With Dry Eye Disease

NCT01753596 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2014-11-14

No results posted yet for this study

Summary

Dry eye syndrome (DES) is a highly prevalent ocular condition with severe consequences for the patients reaching from ocular discomfort in its simplest form up to visual impairment and corneal ulceration in severe cases. Data from epidemiological studies indicate that DES is a common disease, especially in the elderly population, affecting up to 20% of adults aged 45 years or older. Topical lubricants are a mainstay of therapy, but data on its effect on tear film thickness and the corneal residence time are lacking.

Recently, a new objective method for assessment of tear film thickness by optical coherence tomography has been developed. The present study aims to investigate the corneal residence time of an established topical lubricant compared to placebo in patients with DES and healthy controls.

Conditions

  • Dry Eye Syndrome

Interventions

DEVICE

GENTEAL HA® Eye Drops (NOVARTIS, Switzerland)

OTHER

Physiological Sodium Chloride solution (0,9%)

Placebo

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2014-12-31
Completion
2015-02-28

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01753596 on ClinicalTrials.gov