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

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

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

Study Overview

• Status: Completed
• Conditions: Moderate Dry Eye Syndrome
• Intervention / Treatment: Other: Thealoz; Other: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Valladolid, Spain, 47011
    • IOBA - University of Valladolid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
• Investigators: Principal Investigator: Maria Jesus Gonzalez, PhD, IOBA - University of Valladolid

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: December 4, 2012
• First Submitted That Met QC Criteria: December 4, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Estimate): January 8, 2015
• Last Update Submitted That Met QC Criteria: January 7, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Dry Eye Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: IOBA-Thea-001-2012