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Effect of Topical Glaucoma Therapy on Tear Film Stability in Healthy Subjects

NCT01746602 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2016-12-02

No results posted yet for this study

Summary

Long term treatment with anti-glaucomatous drugs has been shown to increase the incidence of dry eye syndrome with all known consequences such as ocular discomfort and epithelial keratitis. Given that thinning of the tear film appears to be a risk factor for the development or the aggravation of dry eye syndrome, the current study seeks to investigate whether tear film thickness is changed after topical treatment with anti-glaucomatous drugs in healthy subjects.

For this purpose, tear film thickness will be measured at baseline and after single instillation of one of 5 study drugs in one randomly chosen eye. In addition, one group of 20 subjects will receive no drug and will serve as a second control. Drug effects on tear film thickness will be compared to the fellow, non-treated eye. In addition, effects on tear film thickness of timolol with preservatives (Timoptic 0.5%) will be compared to timolol without preservatives (Timophtal sine 0.5%) and three lubricants with different viscosity (Genteal HA, Hylo-Comod, Thealoz).

Conditions

  • Healthy

Interventions

DRUG

Timoptic® 0.5%

Timoptic® 0.5% Eye Drops, Merck, single instillation

DRUG

Timophtal sine® 0.5%

Timophtal sine® 0.5%, Agepha, Eye Drops, single instillation

DEVICE

Genteal HA®

Genteal HA® Eye Drops, Novartis, single instillation

DEVICE

Hylo-Comod®

Hylo-Comod® Eye Drops, Croma-Pharma, single instillation

DEVICE

Thealoz®

Thealoz® Eye Drops, Thea, France, single instillation

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-09-30
Completion
2015-01-31

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 NCT01746602 on ClinicalTrials.gov