The purpose of this study is to determine if Thealoz is effective in Dry Eye Syndrome exposed
to controlled adverse environmental conditions.
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Locations near you
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Full eligibility criteria for NCT01742884
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT01742884
IOBA - University of Valladolid
Valladolid, Spain, 47011
View full eligibility
Tris trial is registered with FDA with number: NCT01742884. The sponsor of the trial is Instituto Universitario de Oftalmobiología Aplicada and it is looking for 50 volunteers for the current phase.
Official trial title: Evaluation of the Efficacy and Safety of a Treatment for Dry Eye Syndrome: Thealoz
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