Influence of Lachrymal Substitutes on Tear Film Thickness in Patients With Moderate Dry Eye Syndrome

Study Overview
=================
Brief Summary
-----------------
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, information about the 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 optical coherence tomography (OCT) has become available. The aim of the present study is to assess corneal residence time of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Hyabak® Eye Drops and Hydrabak® Eye Drops in patients with moderate dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test and determination of tear break up time (BUT) will be performed..

Official Title
-----------------
Influence of Lachrymal Substitutes on Tear Film Thickness in Patients With Moderate Dry Eye Syndrome

Conditions
-----------------
Dry Eye Syndrome

Intervention / Treatment
-----------------
* Device: Thealoz Duo®
* Device: Hyabak®
* Device: Hydrabak®


Participation Criteria
=================
Eligibility Criteria
-----------------
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 (Ocular Surface Disease Index) ≤ 32 and ≥ 13 Normal ophthalmic findings except dry eye syndrome, ametropia < 6 Dpt. No administration of topical lubricants 24 hours before the screening examination Exclusion Criteria: Participation in a clinical trial in the 3 weeks preceding the study Symptoms of a clinically relevant illness in the 3 weeks before the first study day Presence or history of a severe medical condition as judged by the clinical investigator Intake of parasympathomimetic or anti-psychotic drugs Wearing of contact lenses Glaucoma Treatment with corticosteroids in the 4 weeks preceding the study Topical treatment with any ophthalmic drug except topical lubricants in the 4 weeks preceding the study Ocular infection or clinically significant inflammation Ocular surgery in the 3 months preceding the study Sjögren's syndrome Stevens-Johnson syndrome History of allergic conjunctivitis Ametropia >= 6 Dpt Pregnancy, planned pregnancy or lactating Known hypersensitivity to any component of the study medication. Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease Inability to understand the study procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dry Eye Syndrome I<br>20 patients with moderate dry eye syndrome | Device: Thealoz Duo®<br>* Eye Drops<br>|
| Active Comparator: Dry Eye Syndrome II<br>20 patients with moderate dry eye syndrome | Device: Hyabak®<br>* Eye Drops<br>|
| Active Comparator: Dry Eye Syndrome III<br>20 patients with moderate dry eye syndrome | Device: Hydrabak®<br>* Eye Drops<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear film thickness | Change in tear film thickness as measured with OCT. Total time frame is 4 hours | Change in tear film thickness from predose to 10 ± 3 minutes, 20 ± 3 minutes, 40 ± 5 minutes, 60 ± 5 minutes, 120 ± 10 minutes and 240 ± 10 minutes after instillation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Break Up Time | Total time frame is 14 days | change from screening to the last OCT measurement | 
| Subjective evaluation of ocular comfort | Ocular comfort will be assessed immediately after instillation and at the end of the study day. Total time frame is 4 hours. | change after instillation and after the last OCT measurement | 
| Schirmer I test | Total time frame is 14 days | change from screening to after the last OCT measurement | 
| Visual Acuity | Total time frame is 14 days. | change from screening to after the last OCT measurement | 
| Intraocular Pressure | Total time frame is 14 days | change from screening to after the last OCT measurement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
topical lubricants, optical coherence tomography, tear break up time, Schirmer I test