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

Dry Eye Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864330
• Other study ID #: OPHT-28102012
• Status: Completed
• Phase: Phase 4
• First received: May 3, 2013
• Last updated: November 26, 2013
• Start date: May 2013
• Est. completion date: September 2013

Study information

• Verified date: November 2013
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Device:
• Thealoz Duo®
Eye Drops
• Hyabak®
Eye Drops
• Hydrabak®
Eye Drops

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Tear Break Up Time	Total time frame is 14 days	change from screening to the last OCT measurement	No
Secondary	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	No
Secondary	Schirmer I test	Total time frame is 14 days	change from screening to after the last OCT measurement	No
Secondary	Visual Acuity	Total time frame is 14 days.	change from screening to after the last OCT measurement	No
Secondary	Intraocular Pressure	Total time frame is 14 days	change from screening to after the last OCT measurement	No