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

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA1 site in 1 country50 target enrollmentDecember 2012

ConditionsModerate Dry Eye Syndrome

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Moderate Dry Eye Syndrome
Sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Enrollment: 50
Locations: 1
Primary Endpoint: Proportion of patients with fluorescein corneal staining reduction of at least 1 point
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

December 2012

End Date

June 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

Responsible Party

Sponsor

Eligibility Criteria

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.