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

Primary Purpose

Moderate Dry Eye Syndrome

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Thealoz
Vehicle
Sponsored by
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate Dry Eye Syndrome focused on measuring Dry Eye Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IOBA - University of Valladolid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Thealoz

Treatment with Thealoz´s vehicle

Arm Description

Treatment with Thealoz (Trehalose) 3% for 1 month

Treatment with Thealoz´s vehicle for 1 month

Outcomes

Primary Outcome Measures

Proportion of patients with fluorescein corneal staining reduction of at least 1 point
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
Best Corrected Visual Acuity at Exit visit compared to baseline visit
Intraocular pressure
Pathological elevations of intraocular pressure from baseline
Eye fundus alterations
Presence of any pathological finding in eye fundus while the patient is in the study
Corneal Pachymetry
Changes in corneal thickness along the study

Full Information

First Posted
December 4, 2012
Last Updated
January 7, 2015
Sponsor
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
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1. Study Identification

Unique Protocol Identification Number
NCT01742884
Brief Title
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

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Dry Eye Syndrome
Keywords
Dry Eye Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thealoz
Arm Type
Experimental
Arm Description
Treatment with Thealoz (Trehalose) 3% for 1 month
Arm Title
Treatment with Thealoz´s vehicle
Arm Type
Placebo Comparator
Arm Description
Treatment with Thealoz´s vehicle for 1 month
Intervention Type
Other
Intervention Name(s)
Thealoz
Other Intervention Name(s)
Thealoz, Trehalose
Intervention Description
Instillation of 1 drop of Thealoz
Intervention Type
Other
Intervention Name(s)
Vehicle
Other Intervention Name(s)
Instillation of Thealoz´s vehicle
Intervention Description
1 drop of the vehicle will be instillated in the eye
Primary Outcome Measure Information:
Title
Proportion of patients with fluorescein corneal staining reduction of at least 1 point
Description
Proportion of subjects with staining reduction within the treatment group vs proportion of staining reduction in control group
Time Frame
1 Month
Secondary Outcome Measure Information:
Title
Best Corrected Visual Acuity
Description
Best Corrected Visual Acuity at Exit visit compared to baseline visit
Time Frame
1 month
Title
Intraocular pressure
Description
Pathological elevations of intraocular pressure from baseline
Time Frame
1 month
Title
Eye fundus alterations
Description
Presence of any pathological finding in eye fundus while the patient is in the study
Time Frame
1 month
Title
Corneal Pachymetry
Description
Changes in corneal thickness along the study
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Jesus Gonzalez, PhD
Organizational Affiliation
IOBA - University of Valladolid
Official's Role
Principal Investigator
Facility Information:
Facility Name
IOBA - University of Valladolid
City
Valladolid
ZIP/Postal Code
47011
Country
Spain

12. IPD Sharing Statement

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

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