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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT01864330

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

14.8

Patients Per Site Per Month

Study Details

Study Description

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..

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Device: Thealoz Duo® Device: Hyabak® Device: Hydrabak®	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.
Schirmer I test [change from screening to after the last OCT measurement]
Total time frame is 14 days
Visual Acuity [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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