NCT01746602

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_3 healthy

Timeline
Completed

Started Jul 2011

Longer than P75 for phase_3 healthy

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2012

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

December 2, 2016

Status Verified

December 1, 2016

Enrollment Period

1.2 years

First QC Date

December 7, 2012

Last Update Submit

December 1, 2016

Conditions

Healthy

Keywords

topical lubricantstear film thicknessanti-glaucoma drugsbreak up timeanti-glaucoma treatment

Outcome Measures

Primary Outcomes (1)

  • Tear film thickness

    up to 1 hour

Secondary Outcomes (1)

  • Break up time (BUT)

    once on the study day

Study Arms (6)

healthy subjects I

EXPERIMENTAL

20 healthy subjects

Drug: Timoptic® 0.5%

healthy subjects II

EXPERIMENTAL

20 healthy subjects

Drug: Timophtal sine® 0.5%

healthy subjects III

EXPERIMENTAL

20 healthy subjects

Device: Genteal HA®

healthy subjects IV

EXPERIMENTAL

20 healthy subjects

Device: Hylo-Comod®

healthy subjects V

EXPERIMENTAL

20 healthy subjects

Device: Thealoz®

healthy subjects VI

NO INTERVENTION

20 healthy subjects

Interventions

Timoptic® 0.5%DRUG

Timoptic® 0.5% Eye Drops, Merck, single instillation

healthy subjects I
Timophtal sine® 0.5%DRUG

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

healthy subjects II
Genteal HA®DEVICE

Genteal HA® Eye Drops, Novartis, single instillation

healthy subjects III
Hylo-Comod®DEVICE

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

healthy subjects IV
Thealoz®DEVICE

Thealoz® Eye Drops, Thea, France, single instillation

healthy subjects V

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

  • 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.

    PMID: 23847319DERIVED

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. PD Dr.

Study Record Dates

First Submitted

December 7, 2012

First Posted

December 11, 2012

Study Start

July 1, 2011

Primary Completion

September 1, 2012

Study Completion

January 1, 2015

Last Updated

December 2, 2016

Record last verified: 2016-12

Locations

AU(1)