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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01746602
First received: December 7, 2012
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention Phase
Healthy
Drug: Timoptic® 0.5%
Drug: Timophtal sine® 0.5%
Device: Genteal HA®
Device: Hylo-Comod®
Device: Thealoz®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Topical Glaucoma Therapy on Tear Film Stability in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Tear film thickness [ Time Frame: up to 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Break up time (BUT) [ Time Frame: once on the study day ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: healthy subjects I
20 healthy subjects
Drug: Timoptic® 0.5%
Timoptic® 0.5% Eye Drops, Merck, single instillation
Experimental: healthy subjects II
20 healthy subjects
Drug: Timophtal sine® 0.5%
Timophtal sine® 0.5%, Agepha, Eye Drops, single instillation
Experimental: healthy subjects III
20 healthy subjects
Device: Genteal HA®
Genteal HA® Eye Drops, Novartis, single instillation
Experimental: healthy subjects IV
20 healthy subjects
Device: Hylo-Comod®
Hylo-Comod® Eye Drops, Croma-Pharma, single instillation
Experimental: healthy subjects V
20 healthy subjects
Device: Thealoz®
Thealoz® Eye Drops, Thea, France, single instillation
No Intervention: healthy subjects VI
20 healthy subjects

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746602

Contacts
Contact: Gerhard Garhoefer, MD +43140400 ext 2981 gerhard.garhoefer@meduniwien.ac.at

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Gerhard Garhoefer, MD    +43140400 ext 2981    gerhard.garhoefer@meduniwien.ac.at   
Principal Investigator: Gerhard Garhoefer, MD         
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01746602     History of Changes
Other Study ID Numbers: OPHT-241010
Study First Received: December 7, 2012
Last Updated: July 11, 2013
Health Authority: Austria: Austrian Medicines and Medical Devices Agency

Keywords provided by Medical University of Vienna:
topical lubricants
tear film thickness
anti-glaucoma drugs
break up time
anti-glaucoma treatment

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Timolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents

ClinicalTrials.gov processed this record on July 20, 2014