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

NCT ID: NCT01742884

Last Updated: 2015-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Thealoz

Treatment with Thealoz (Trehalose) 3% for 1 month

Group Type: EXPERIMENTAL

Thealoz

Intervention Type: OTHER

Instillation of 1 drop of Thealoz

Treatment with Thealoz´s vehicle

Treatment with Thealoz´s vehicle for 1 month

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: OTHER

1 drop of the vehicle will be instillated in the eye

Interventions

Thealoz

Instillation of 1 drop of Thealoz

Intervention Type: OTHER

Vehicle

1 drop of the vehicle will be instillated in the eye

Intervention Type: OTHER

Other Intervention Names

Thealoz, Trehalose; Instillation of Thealoz´s vehicle

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Jesus Gonzalez, PhD

Role: PRINCIPAL_INVESTIGATOR

IOBA - University of Valladolid

Locations

IOBA - University of Valladolid

Valladolid, Valladolid, Spain

Countries

Spain

Other Identifiers

IOBA-Thea-001-2012

Identifier Type: -

Identifier Source: org_study_id