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

Phase 4

Completed

• Conditions: Moderate Dry Eye Syndrome
• Interventions: Other: Vehicle; Other: Thealoz

• Registration Number: NCT01742884
• Lead Sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-04
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-07
• Last Update Posted: 2015-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment with Thealoz´s vehicle	Vehicle	Treatment with Thealoz´s vehicle for 1 month
Thealoz	Thealoz	Treatment with Thealoz (Trehalose) 3% for 1 month

Primary Outcome Measures

Name	Time	Method
Proportion of patients with fluorescein corneal staining reduction of at least 1 point	1 Month	Proportion of subjects with staining reduction within the treatment group vs proportion of staining reduction in control group

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IOBA - University of Valladolid; 🇪🇸 Valladolid, Spain