Added Benefits of Lachrymal Substitute Gel During the Night 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. Relief of symptoms in patients with moderate to severe dry eye disease is usually reached by the use of artificial tears during the day. Nighttime relief is often achieved by substances known to be more adhesive to the ocular surface, such as gels.

Official Title
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Added Benefits of Lachrymal Substitute Gel During the Night in Patients With Moderate to Severe Dry Eye Syndrome

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Device: Thealoz Duo Gel and Thealoz Duo eye drops
* Device: Thealoz Duo 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 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 administered medical device product, fluorescein or lissamine green 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, neoplastic, hematological 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 sterilized. 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.

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with dry eye syndrome 1<br>20 patients with dry eye syndrome, they will receive intervention 1 for one week and then cross over to intervention 2 | Device: Thealoz Duo Gel and Thealoz Duo eye drops<br>* Thealoz Duo gel at night (1 drop before going to bed) + Thealoz Duo eye drops during the day (4 to 6 drops per day)<br>* Other names: Intervention 1;Device: Thealoz Duo eye drops<br>* Thealoz Duo eye drops during the day (4 to 6 drops per day)<br>* Other names: Intervention 2;|
| Experimental: Patients with dry eye syndrome 2<br>20 patients with dry eye syndrome, they will receive intervention 2 for one week and then cross over to intervention 1 | Device: Thealoz Duo Gel and Thealoz Duo eye drops<br>* Thealoz Duo gel at night (1 drop before going to bed) + Thealoz Duo eye drops during the day (4 to 6 drops per day)<br>* Other names: Intervention 1;Device: Thealoz Duo eye drops<br>* Thealoz Duo eye drops during the day (4 to 6 drops per day)<br>* Other names: Intervention 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction when awakening (VAS) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 4 weeks | 
| Number of drops of Thealoz Duo instilled during the day (patient diary) |  | 4 weeks | 
| Tear break up time |  | 4 weeks | 
| Conjunctival and corneal staining |  | 4 weeks | 
| Schirmer 1 Test |  | 4 weeks | 
| OSDI questionnaire | Ocular Surface Disease Index Questionnaire | 4 weeks |