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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01742884
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : January 8, 2015
Information provided by (Responsible Party):
Instituto Universitario de Oftalmobiología Aplicada

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

Condition or disease Intervention/treatment Phase
Moderate Dry Eye Syndrome Other: Thealoz Other: Vehicle Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of a Treatment for Dry Eye Syndrome: Thealoz
Study Start Date : December 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: Thealoz
Treatment with Thealoz (Trehalose) 3% for 1 month
Other: Thealoz
Instillation of 1 drop of Thealoz
Other Name: 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 Name: Instillation of Thealoz´s vehicle

Primary Outcome Measures :
  1. Proportion of patients with fluorescein corneal staining reduction of at least 1 point [ Time Frame: 1 Month ]
    Proportion of subjects with staining reduction within the treatment group vs proportion of staining reduction in control group

Secondary Outcome Measures :
  1. Best Corrected Visual Acuity [ Time Frame: 1 month ]
    Best Corrected Visual Acuity at Exit visit compared to baseline visit

  2. Intraocular pressure [ Time Frame: 1 month ]
    Pathological elevations of intraocular pressure from baseline

  3. Eye fundus alterations [ Time Frame: 1 month ]
    Presence of any pathological finding in eye fundus while the patient is in the study

  4. Corneal Pachymetry [ Time Frame: 1 month ]
    Changes in corneal thickness along the study

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01742884

IOBA - University of Valladolid
Valladolid, Spain, 47011
Sponsors and Collaborators
Instituto Universitario de Oftalmobiología Aplicada
Principal Investigator: Maria Jesus Gonzalez, PhD IOBA - University of Valladolid

Responsible Party: Instituto Universitario de Oftalmobiología Aplicada Identifier: NCT01742884     History of Changes
Other Study ID Numbers: IOBA-Thea-001-2012
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: January 8, 2015
Last Verified: January 2015

Keywords provided by Instituto Universitario de Oftalmobiología Aplicada:
Dry Eye Syndrome

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Pathologic Processes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases