Efficacy and Safety of a Treatment for Dry Eye Syndrome: Thealoz

Study Overview
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Brief Summary
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The purpose of this study is to determine if Thealoz is effective in Dry Eye Syndrome exposed to controlled adverse environmental conditions.

Official Title
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Evaluation of the Efficacy and Safety of a Treatment for Dry Eye Syndrome: Thealoz

Conditions
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Moderate Dry Eye Syndrome

Intervention / Treatment
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* Other: Thealoz
* Other: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Man/woman ≥ 18 years old, able to freely give consent to participate in the study Fluorescein corneal staining ≥ 1 and ≤ 3 in Oxford Scales At least 2 of the following tests altered: Ocular Surface Disease Index (OSDI) Test symptoms between 12 and 40 BUT ≤10 seconds Lissamine green conjunctival staining ≥ 1 Schirmer Test without anesthesia ≤ 5 mm Informed consent signed Data protection consent signed Exclusion Criteria: Sensitivity or known intolerance to any of the product used in the study Story of ocular infections or severe ocular inflammation within the 6 previous months to study inclusion Any active ocular pathology other than Dry Eye Syndrome Any traumatize or ocular surgery that may affect corneal sensitivity and/or normal tear distribution (e.g. cataract surgery, refractive surgery) within the 6 previous months to study inclusion Use of contact lenses in the 3 previous months to study inclusion Use of any ocular topical medications other than the treatment for Dry Eye Syndrome Ocular treatment for Dry Eye Syndrome with corticosteroids 1 month before inclusion visit or Cyclosporin A 3 months before inclusion Diagnosis of Rosacea or Severe Blepharitis (associated to systemic or ocular pathologies) Any severe uncontrolled systemic disease that may affect the eye (except for primary or secondary Sjögren) Start, discontinuation or change within the study of the dosage of antihistaminics, cholinergic agents, beta blockers, anti depressants or any other systemic drugs with potential effects in the tear film No pregnant or breastfeeding women is allowed to participate in the study. Childbearing potential women must use contraceptive means during the whole study. Participation in another clinical trial in the last 30 days before study inclusion

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thealoz<br>Treatment with Thealoz (Trehalose) 3% for 1 month | Other: Thealoz<br>* Instillation of 1 drop of Thealoz<br>* Other names: Thealoz, Trehalose;|
| Placebo Comparator: Treatment with Thealoz´s vehicle<br>Treatment with Thealoz´s vehicle for 1 month | Other: Vehicle<br>* 1 drop of the vehicle will be instillated in the eye<br>* Other names: Instillation of Thealoz´s vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with fluorescein corneal staining reduction of at least 1 point | Proportion of subjects with staining reduction within the treatment group vs proportion of staining reduction in control group | 1 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity | Best Corrected Visual Acuity at Exit visit compared to baseline visit | 1 month | 
| Intraocular pressure | Pathological elevations of intraocular pressure from baseline | 1 month | 
| Eye fundus alterations | Presence of any pathological finding in eye fundus while the patient is in the study | 1 month | 
| Corneal Pachymetry | Changes in corneal thickness along the study | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye Syndrome