Influence of Three Different Formulations of Lachrymal Substitutes on Tear Film Thickness and Other Signs and Symptoms in Patients With Moderate to Severe Dry Eye Syndrome

Study Overview
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Brief Summary
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Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the elderly population. Topically administered lubricants are the basis for treatment of this disease. However, exact information about influence on tear film thickness and corneal residence time of topical lubricants is still sparse, therefore no ideal treatment regimen has been found. Recently a new method for assessment of tear film thickness based on ultra-high resolution optical coherence tomography (OCT) has become available. The aim of the present study is to assess the influence on tear film thickness of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Optive® Eye Drops and Systane Ultra® Eye Drops in patients with moderate to severe dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test, corneal fluorescein staining and determination of tear break up time (BUT) will be performed to compare the product effects.

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Device: Thealoz Duo Eye Drops
* Device: Optive Eye Drops
* Device: Systane Ultra Eye Drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged over 18 years Signed and dated written informed consent History of dry eye syndrome for at least 3 months Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm OSDI ≥ 22 Normal ophthalmic findings except dry eye syndrome, ametropia < 6 Dpt. No administration of topical lubricants 24 hours before the screening examination Exclusion Criteria: Presence of an ocular pathology judged by the investigator as incompatible with the study. Any other clinical relevant ocular abnormality except DES. History of allergy, known hypersensitivity to one of the components: the study medications or Fluorescein. History of known clinically relevant allergy. Medical or surgical history judged by the investigator to be incompatible with the study participation (hepatic or renal insufficiency; all chronic severe organic disease: metabolic, endocrine, neoplasic, haematological disease; severe psychiatric illness, etc.). History of a recent acute illness with a recovery period within the 2 weeks before the inclusion visit (Day 0). Pregnancy, lactation. Pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) or is not surgically sterilised. Participation in any high-speed or water-sports during the study without ocular protection (goggles or glasses). Subject unable to understand the study instructions or unlikely to comply with the study schedule and treatment. Participation in another clinical study in the 4 weeks before the start of the present study or at the same time as the present study. Subject is a ward of court.

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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No

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: Experimental: Patients with dry eye syndrome 1<br>40 Patients with dry eye syndrome | Device: Thealoz Duo Eye Drops<br>* Manufacturer: Laboratoires Thea, France<br>|
| Active Comparator: Experimental: Patients with dry eye syndrome 2<br>40 Patients with dry eye syndrome | Device: Optive Eye Drops<br>* Manufacturer: Allergan Pharmaceuticals, Ireland<br>|
| Active Comparator: Experimental: Patients with dry eye syndrome 3<br>40 Patients with dry eye syndrome | Device: Systane Ultra Eye Drops<br>* Manufacturer: Alcon Pharma GmbH<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in tear film thickness as measured with Optical Coherence Tomography (OCT) | Tear film thickness as measured with Optical Coherence Tomography (OCT) predose and at defined time points after the first instillation, as well as on each study day | 10 weeks; at baseline, 10 minutes, 20 minutes, 40 minutes, 60 minutes, 120 minutes and 240 minutes after instillation of eye drops as well as 4 weeks and 8 weeks after the first instillation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Break Up Time (BUT) |  | 10 weeks | 
| Subjective evaluation of ocular comfort with questionnaire |  | 10 weeks | 
| Schirmer I test |  | 10 weeks | 
| OSDI score |  | 10 weeks | 
| Corneal fluorescein staining (Oxford grading scale) |  | 10 weeks | 
| Conjunctival hyperemia score |  | 10 weeks | 
| Efficacy assessment of eye drops by the patient with questionnaire | Efficacy of eye drops will be performed by the patient by choosing one of the following options: Very satisfactory Satisfactory Not very satisfactory Unsatisfactory | 10 weeks | 
| Efficacy assessment of eye drops by the investigator with questionnaire | Efficacy of eye drops will be performed by the investigator by choosing one of the following options: Very satisfactory Satisfactory Not very satisfactory Unsatisfactory | 10 weeks |