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Influence of Lachrymal Substitutes on Tear Film Thickness in Patients With Moderate Dry Eye Syndrome

NCT ID: NCT01864330

Last Updated: 2013-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-09-30

Brief Summary

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Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the elderly population. Topically administered lubricants are the basis for treatment of this disease. However, information about the corneal residence time of topical lubricants is still sparse, therefore no ideal treatment regimen has been found.

Recently a new method for assessment of tear film thickness based on optical coherence tomography (OCT) has become available. The aim of the present study is to assess corneal residence time of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Hyabak® Eye Drops and Hydrabak® Eye Drops in patients with moderate dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test and determination of tear break up time (BUT) will be performed..

Detailed Description

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Conditions

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Dry Eye Syndrome

Keywords

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topical lubricants optical coherence tomography tear break up time Schirmer I test

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Dry Eye Syndrome I

20 patients with moderate dry eye syndrome

Group Type EXPERIMENTAL

Thealoz Duo®

Intervention Type DEVICE

Eye Drops

Dry Eye Syndrome II

20 patients with moderate dry eye syndrome

Group Type ACTIVE_COMPARATOR

Hyabak®

Intervention Type DEVICE

Eye Drops

Dry Eye Syndrome III

20 patients with moderate dry eye syndrome

Group Type ACTIVE_COMPARATOR

Hydrabak®

Intervention Type DEVICE

Eye Drops

Interventions

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Thealoz Duo®

Eye Drops

Intervention Type DEVICE

Hyabak®

Eye Drops

Intervention Type DEVICE

Hydrabak®

Eye Drops

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Men and women aged over 18 years
* Signed and dated written informed consent.
* History of dry eye syndrome for at least 3 months
* Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm
* OSDI (Ocular Surface Disease Index) ≤ 32 and ≥ 13
* Normal ophthalmic findings except dry eye syndrome, ametropia \< 6 Dpt.
* No administration of topical lubricants 24 hours before the screening examination

Exclusion Criteria

* Participation in a clinical trial in the 3 weeks preceding the study
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Presence or history of a severe medical condition as judged by the clinical investigator
* Intake of parasympathomimetic or anti-psychotic drugs
* Wearing of contact lenses
* Glaucoma
* Treatment with corticosteroids in the 4 weeks preceding the study
* Topical treatment with any ophthalmic drug except topical lubricants in the 4 weeks preceding the study
* Ocular infection or clinically significant inflammation
* Ocular surgery in the 3 months preceding the study
* Sjögren's syndrome
* Stevens-Johnson syndrome
* History of allergic conjunctivitis
* Ametropia \>= 6 Dpt
* Pregnancy, planned pregnancy or lactating
* Known hypersensitivity to any component of the study medication.
* Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease
* Inability to understand the study procedures
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Garhofer

Assoc. Prof. PD Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gerhard Garhoefer, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Medical University of Vienna

Locations

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Department of Clinical Pharmacology

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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OPHT-28102012

Identifier Type: -

Identifier Source: org_study_id