Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects

Study Overview
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Brief Summary
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Dry eye syndrome (DES) is a common ocular disease, especially in the elderly population. Despite many treatment approaches, instillation of topical lubricants remains the mainstay of therapy. However, most of the topical lubricants available are not very well characterized and data about efficacy is sparse. The aim of the present project is to investigate the effect of topically administered Olixia pure® eye drops on tear film thickness in healthy subjects. Tear film thickness will be determined using ultra high-resolution optical coherence tomography (OCT). Measurements will be performed before instillation of the eye drops and every 10 minutes after instillation for one hour. One eye will receive Olixia pure® eye drops, the fellow eye will receive physiologic saline solution as placebo control. The study eye will be chosen randomly.

Official Title
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Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects

Conditions
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Dry Eye Syndrome, Healthy

Intervention / Treatment
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* Device: Olixia pure eye drops
* Device: Placebo


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 unless the investigator considers an abnormality to be clinically irrelevant Normal ophthalmic findings, ametropia < 6 Dpt. Schirmer I test > 10 mm and BUT > 10 sec 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 Ametropia =/> 6 Dpt Pregnancy Difference of more than 5 mm in Schirmer I test or difference of > 3 sec in BUT between the two eyes Known medical history of allergy, hypersensitivity or poor tolerance to any components of the medication or medical product used in the study

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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy volunteers right eye<br>The medical device will be randomly assigned to the right or left eye on the study day (randomization 1:1) whereas the fellow eye will receive placebo. | Device: Olixia pure eye drops<br> <br> Device: Placebo<br>* 0.9% physiological saline solution<br>|
| Other: Healthy volunteers left eye<br>The medical device will be randomly assigned to the right or left eye on the study day (randomization 1:1) whereas the fellow eye will receive placebo. | Device: Olixia pure eye drops<br> <br> Device: Placebo<br>* 0.9% physiological saline solution<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tear film thickness, optical coherence tomography, topical lubricants, tear film thickness in healthy subjects