Assessment of Tear Film Thickness by Optical Coherence Tomography in Healthy Subjects and Subjects With Dry Eye Disease

Study Overview
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Brief Summary
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Dry eye syndrome (DES) is a highly prevalent ocular condition with severe consequences for the patients reaching from ocular discomfort in its simplest form up to visual impairment and corneal ulceration in severe cases. Data from epidemiological studies indicate that DES is a common disease, especially in the elderly population, affecting up to 20% of adults aged 45 years or older. Topical lubricants are a mainstay of therapy, but data on its effect on tear film thickness and the corneal residence time are lacking. Recently, a new objective method for assessment of tear film thickness by optical coherence tomography has been developed. The present study aims to investigate the corneal residence time of an established topical lubricant compared to placebo in patients with DES and healthy controls.

Official Title
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Assessment of Tear Film Thickness by Optical Coherence Tomography in Healthy Subjects and Subjects With Dry Eye Disease

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Device: GENTEAL HA® Eye Drops (NOVARTIS, Switzerland)
* Other: Physiological Sodium Chloride solution (0,9%)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria for healthy subjects: 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 Inclusion criteria for patients with dry eye syndrome: Men and women aged over 18 years Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant except DES Normal ophthalmic findings, ametropia < 6 Dpt History of dry eye syndrome for at least 3 months Tear Break Up Time (BUT) < 10 seconds or Schirmer I test < 7 mm At least 2 symptoms of dry eye syndrome (foreign body sensation, burning, photophobia, blurred vision, pain, itching) Normal ophthalmic findings except dry eye syndrome 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 3 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 30 healthy subjects<br>Subjects will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo | Device: GENTEAL HA® Eye Drops (NOVARTIS, Switzerland)<br> <br> Other: Physiological Sodium Chloride solution (0,9%)<br>* Placebo<br>|
| Experimental: 30 patients with dry eye syndrome<br>Patients will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo | Device: GENTEAL HA® Eye Drops (NOVARTIS, Switzerland)<br> <br> Other: Physiological Sodium Chloride solution (0,9%)<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear film thickness |  | change from baseline to 1 hour after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Schirmer I Test | once on the study day | 1 day | 
| Tear Break Up Time | once on the study day | 1 day | 
| Ocular Surface Disease Index | once on the study day | 1 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, break up time, ocular surface disease index, Schirmer I test