Healthy
Conditions
Keywords
topical lubricants, tear film thickness, anti-glaucoma drugs, break up time, anti-glaucoma treatment
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).
Interventions
DRUGTimoptic® 0.5%
Timoptic® 0.5% Eye Drops, Merck, single instillation
DRUGTimophtal sine® 0.5%
Timophtal sine® 0.5%, Agepha, Eye Drops, single instillation
DEVICEGenteal HA®
Genteal HA® Eye Drops, Novartis, single instillation
DEVICEHylo-Comod®
Hylo-Comod® Eye Drops, Croma-Pharma, single instillation
DEVICEThealoz®
Thealoz® Eye Drops, Thea, France, single instillation
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tear film thickness | up to 1 hour |
Secondary
| Measure | Time frame |
|---|---|
| Break up time (BUT) | once on the study day |
Countries
Austria
Outcome results
None listed