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

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..

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Device: Thealoz Duo®; Device: Hyabak®; Device: Hydrabak®

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Department of Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry Eye Syndrome I; 20 patients with moderate dry eye syndrome	Device: Thealoz Duo®; Eye Drops
Active Comparator: Dry Eye Syndrome II; 20 patients with moderate dry eye syndrome	Device: Hyabak®; Eye Drops
Active Comparator: Dry Eye Syndrome III; 20 patients with moderate dry eye syndrome	Device: Hydrabak®; Eye Drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear film thickness	Change in tear film thickness as measured with OCT. Total time frame is 4 hours	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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: May 3, 2013
• First Submitted That Met QC Criteria: May 24, 2013
• First Posted (Estimate): May 29, 2013

Study Record Updates

• Last Update Posted (Estimate): November 27, 2013
• Last Update Submitted That Met QC Criteria: November 26, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: optical coherence tomography; topical lubricants; tear break up time; Schirmer I test
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: OPHT-28102012