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

Study Overview
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Brief Summary
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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).

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Timoptic® 0.5%
* Drug: Timophtal sine® 0.5%
* Device: Genteal HA®
* Device: Hylo-Comod®
* Device: Thealoz®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: healthy subjects I<br>20 healthy subjects | Drug: Timoptic® 0.5%<br>* Timoptic® 0.5% Eye Drops, Merck, single instillation<br>|
| Experimental: healthy subjects II<br>20 healthy subjects | Drug: Timophtal sine® 0.5%<br>* Timophtal sine® 0.5%, Agepha, Eye Drops, single instillation<br>|
| Experimental: healthy subjects III<br>20 healthy subjects | Device: Genteal HA®<br>* Genteal HA® Eye Drops, Novartis, single instillation<br>|
| Experimental: healthy subjects IV<br>20 healthy subjects | Device: Hylo-Comod®<br>* Hylo-Comod® Eye Drops, Croma-Pharma, single instillation<br>|
| Experimental: healthy subjects V<br>20 healthy subjects | Device: Thealoz®<br>* Thealoz® Eye Drops, Thea, France, single instillation<br>|
| No Intervention: healthy subjects VI<br>20 healthy subjects | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear film thickness |  | up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Break up time (BUT) |  | once on the study day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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topical lubricants, tear film thickness, anti-glaucoma drugs, break up time, anti-glaucoma treatment