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

This study is currently recruiting participants.
Verified December 2012 by Instituto Universitario de Oftalmobiología Aplicada
Sponsor:
Information provided by (Responsible Party):
Instituto Universitario de Oftalmobiología Aplicada
ClinicalTrials.gov Identifier:
NCT01742884
First received: December 4, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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


Condition Intervention Phase
Moderate Dry Eye Syndrome
 Other: Thealoz
Other: Vehicle
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of a Treatment for Dry Eye Syndrome: Thealoz

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto Universitario de Oftalmobiología Aplicada:

Primary Outcome Measures:
  • Proportion of patients with fluorescein corneal staining reduction of at least 1 point [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
    Proportion of subjects with staining reduction within the treatment group vs proportion of staining reduction in control group


Secondary Outcome Measures:
  • Best Corrected Visual Acuity [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Best Corrected Visual Acuity at Exit visit compared to baseline visit

  • Intraocular pressure [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Pathological elevations of intraocular pressure from baseline

  • Eye fundus alterations [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Presence of any pathological finding in eye fundus while the patient is in the study

  • Corneal Pachymetry [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Changes in corneal thickness along the study


Estimated Enrollment: 50
Study Start Date: December 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742884

Contacts
Contact: Maria Jesus Gonzalez, PhD 983184756 aluche@ioba.med.uva.es

Locations
Spain
IOBA - University of Valladolid Recruiting
Valladolid, Spain, 47011
Contact: Maria Jesus Gonzalez, PhD     983184756     aluche@ioba.med.uva.es    
Contact: Francisco Blazquez, MD, MsC     983184734     blazquez@ioba.med.uva.es    
Principal Investigator: Maria Jesus Gonzalez, PhD            
Sub-Investigator: Francisco Blazquez, MD, MsC            
Sub-Investigator: Margarita Calonge-Cano, MD PhD            
Sub-Investigator: Jose Maria Herreras Cantalapiedra, MD PhD            
Sub-Investigator: Alberto Lopez Miguel, PhD            
Sub-Investigator: Marisa Teson Yudego, MsC            
Sub-Investigator: Antonio Abengozar Vela, BsC, MsC            
Sub-Investigator: Vicente Martin Montañez, MsC            
Sub-Investigator: Francisco Jose Pinto Fraga, MsC            
Sponsors and Collaborators
Instituto Universitario de Oftalmobiología Aplicada
Investigators
Principal Investigator: Maria Jesus Gonzalez, PhD IOBA - University of Valladolid
  More Information

No publications provided

Responsible Party: Instituto Universitario de Oftalmobiología Aplicada
ClinicalTrials.gov Identifier: NCT01742884     History of Changes
Other Study ID Numbers: IOBA-Thea-001-2012
Study First Received: December 4, 2012
Last Updated: December 4, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
 Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases

ClinicalTrials.gov processed this record on May 23, 2013