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

Primary Purpose

Healthy

Status
Terminated
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Timoptic® 0.5%
Timophtal sine® 0.5%
Genteal HA®
Hylo-Comod®
Thealoz®
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring topical lubricants, tear film thickness, anti-glaucoma drugs, break up time, anti-glaucoma treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Clinical Pharmacology, Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

healthy subjects I

healthy subjects II

healthy subjects III

healthy subjects IV

healthy subjects V

healthy subjects VI

Arm Description

20 healthy subjects

20 healthy subjects

20 healthy subjects

20 healthy subjects

20 healthy subjects

20 healthy subjects

Outcomes

Primary Outcome Measures

Tear film thickness

Secondary Outcome Measures

Break up time (BUT)

Full Information

First Posted
December 7, 2012
Last Updated
December 1, 2016
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01746602
Brief Title
Effect of Topical Glaucoma Therapy on Tear Film Stability in Healthy Subjects
Official Title
Effect of Topical Glaucoma Therapy on Tear Film Stability in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Study Start Date
July 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
topical lubricants, tear film thickness, anti-glaucoma drugs, break up time, anti-glaucoma treatment

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
healthy subjects I
Arm Type
Experimental
Arm Description
20 healthy subjects
Arm Title
healthy subjects II
Arm Type
Experimental
Arm Description
20 healthy subjects
Arm Title
healthy subjects III
Arm Type
Experimental
Arm Description
20 healthy subjects
Arm Title
healthy subjects IV
Arm Type
Experimental
Arm Description
20 healthy subjects
Arm Title
healthy subjects V
Arm Type
Experimental
Arm Description
20 healthy subjects
Arm Title
healthy subjects VI
Arm Type
No Intervention
Arm Description
20 healthy subjects
Intervention Type
Drug
Intervention Name(s)
Timoptic® 0.5%
Intervention Description
Timoptic® 0.5% Eye Drops, Merck, single instillation
Intervention Type
Drug
Intervention Name(s)
Timophtal sine® 0.5%
Intervention Description
Timophtal sine® 0.5%, Agepha, Eye Drops, single instillation
Intervention Type
Device
Intervention Name(s)
Genteal HA®
Intervention Description
Genteal HA® Eye Drops, Novartis, single instillation
Intervention Type
Device
Intervention Name(s)
Hylo-Comod®
Intervention Description
Hylo-Comod® Eye Drops, Croma-Pharma, single instillation
Intervention Type
Device
Intervention Name(s)
Thealoz®
Intervention Description
Thealoz® Eye Drops, Thea, France, single instillation
Primary Outcome Measure Information:
Title
Tear film thickness
Time Frame
up to 1 hour
Secondary Outcome Measure Information:
Title
Break up time (BUT)
Time Frame
once on the study day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
23847319
Citation
Werkmeister RM, Alex A, Kaya S, Unterhuber A, Hofer B, Riedl J, Bronhagl M, Vietauer M, Schmidl D, Schmoll T, Garhofer G, Drexler W, Leitgeb RA, Groeschl M, Schmetterer L. Measurement of tear film thickness using ultrahigh-resolution optical coherence tomography. Invest Ophthalmol Vis Sci. 2013 Aug 15;54(8):5578-83. doi: 10.1167/iovs.13-11920.
Results Reference
derived

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

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