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

Phase 4

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Device: Hydrabak®; Device: Thealoz Duo®; Device: Hyabak®

• Registration Number: NCT01864330
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-03
• Study First Submitted QC: 2013-05-24
• Study First Posted: 2013-05-29
• Primary Completion: 2013-08
• Study Completion: 2013-09
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-26
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dry Eye Syndrome III	Hydrabak®	20 patients with moderate dry eye syndrome
Dry Eye Syndrome I	Thealoz Duo®	20 patients with moderate dry eye syndrome
Dry Eye Syndrome II	Hyabak®	20 patients with moderate dry eye syndrome

Primary Outcome Measures

Name	Time	Method
Tear film thickness	Change in tear film thickness from predose to 10 ± 3 minutes, 20 ± 3 minutes, 40 ± 5 minutes, 60 ± 5 minutes, 120 ± 10 minutes and 240 ± 10 minutes after instillation	Change in tear film thickness as measured with OCT.; Total time frame is 4 hours

Secondary Outcome Measures

Name	Time	Method
Tear Break Up Time	change from screening to the last OCT measurement	Total time frame is 14 days
Subjective evaluation of ocular comfort	change after instillation and after the last OCT measurement	Ocular comfort will be assessed immediately after instillation and at the end of the study day.; Total time frame is 4 hours.
Visual Acuity	change from screening to after the last OCT measurement	Total time frame is 14 days.
Schirmer I test	change from screening to after the last OCT measurement	Total time frame is 14 days
Intraocular Pressure	change from screening to after the last OCT measurement	Total time frame is 14 days

Trial Locations

Locations (1)

Department of Clinical Pharmacology; 🇦🇹 Vienna, Austria