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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01746602
• Other study ID #: OPHT-241010
• Status: Terminated
• Phase: Phase 3
• First received: December 7, 2012
• Last updated: December 1, 2016
• Start date: July 2011
• Est. completion date: January 2015

Study information

• Verified date: December 2016
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: January 2015
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women aged over 18 years

• Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

• Normal ophthalmic findings, ametropia < 6 Dpt.

Exclusion Criteria:

• Regular use of medication (except contraceptives), abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study

• Treatment in the previous 3 weeks with any drug

• Symptoms of a clinically relevant illness in the 3 weeks before the first study day

• Patients with known hypersensitivity to the study drug or any ingredients

• History or current COPD or asthma

• AV-block grade II or more

• Ametropy = 6 Dpt

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Glaucoma
• Healthy

Intervention

Drug:
• Timoptic® 0.5%
Timoptic® 0.5% Eye Drops, Merck, single instillation
• Timophtal sine® 0.5%
Timophtal sine® 0.5%, Agepha, Eye Drops, single instillation

Device:
• Genteal HA®
Genteal HA® Eye Drops, Novartis, single instillation
• Hylo-Comod®
Hylo-Comod® Eye Drops, Croma-Pharma, single instillation
• Thealoz®
Thealoz® Eye Drops, Thea, France, single instillation

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear film thickness		up to 1 hour	No
Secondary	Break up time (BUT)		once on the study day	No