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

NCT01742884 | Completed Phase 4

• 1 other identifier: IOBA-Thea-001-2012
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Moderate Dry Eye Syndrome

Keywords

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

  1 Month

Secondary Outcomes (4)

• Best Corrected Visual Acuity

  1 month

• Intraocular pressure

  1 month

• Eye fundus alterations

  1 month

• Corneal Pachymetry

  1 month

Study Arms (2)

Thealoz

EXPERIMENTAL

Treatment with Thealoz (Trehalose) 3% for 1 month

Other: Thealoz

Treatment with Thealoz´s vehicle

PLACEBO COMPARATOR

Treatment with Thealoz´s vehicle for 1 month

Other: Vehicle

Interventions

Thealoz OTHER

Instillation of 1 drop of Thealoz

Also known as: Thealoz, Trehalose

Thealoz

Vehicle OTHER

1 drop of the vehicle will be instillated in the eye

Also known as: Instillation of Thealoz´s vehicle

Treatment with Thealoz´s vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Sensitivity or known intolerance to any of the product used in the study
• Any active ocular pathology other than Dry Eye Syndrome
• Use of any ocular topical medications other than the treatment for Dry Eye Syndrome
• 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.

Sponsors & Collaborators

• Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA: lead

Study Sites (1)

IOBA - University of Valladolid

Valladolid, Valladolid, 47011, Spain

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Trehalose

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates; Disaccharides; Oligosaccharides; Sugars

Study Officials

• Maria Jesus Gonzalez, PhD

  IOBA - University of Valladolid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 6, 2012
• Study Start: December 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 8, 2015

Record last verified: 2015-01

Locations

ES (1)