Clinical trial NCT01742884: Efficacy and Safety of a Treatment for Dry Eye Syndrome: Thealoz
Official title: Evaluation of the Efficacy and Safety of a Treatment for Dry Eye Syndrome: Thealoz
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Moderate Dry Eye Syndrome
Keywords: Dry Eye Syndrome
Lead sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.
* Participation in another clinical trial in the last 30 days before study inclusion

Primary outcomes:
measure: Proportion of patients with fluorescein corneal staining reduction of at least 1 point
timeFrame: 1 Month
Secondary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: 1 month
measure: Intraocular pressure
timeFrame: 1 month
measure: Eye fundus alterations
timeFrame: 1 month
measure: Corneal Pachymetry
timeFrame: 1 month
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: IOBA - University of Valladolid
Study officials:
affiliation: IOBA - University of Valladolid
name: Maria Jesus Gonzalez, PhD
role: PRINCIPAL_INVESTIGATOR
References: