Assessment of Tear Film Thickness by Optical Coherence Tomography in Healthy Subjects and Subjects With Dry Eye Disease

Dry eye syndrome (DES) is a highly prevalent ocular condition with severe consequences for the patients reaching from ocular discomfort in its simplest form up to visual impairment and corneal ulceration in severe cases. Data from epidemiological studies indicate that DES is a common disease, especially in the elderly population, affecting up to 20% of adults aged 45 years or older. Topical lubricants are a mainstay of therapy, but data on its effect on tear film thickness and the corneal residence time are lacking.

Recently, a new objective method for assessment of tear film thickness by optical coherence tomography has been developed. The present study aims to investigate the corneal residence time of an established topical lubricant compared to placebo in patients with DES and healthy controls.

Study Overview

• Status: Withdrawn
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Device: GENTEAL HA® Eye Drops (NOVARTIS, Switzerland); Other: Physiological Sodium Chloride solution (0,9%)

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Inclusion criteria for healthy subjects:

• Men and women aged over 18 years
• Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
• Normal ophthalmic findings, ametropia < 6 Dpt
• Schirmer I test > 10 mm and BUT > 10 sec

Inclusion criteria for patients with dry eye syndrome:

• Men and women aged over 18 years
• Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant except DES
• Normal ophthalmic findings, ametropia < 6 Dpt
• History of dry eye syndrome for at least 3 months
• Tear Break Up Time (BUT) < 10 seconds or Schirmer I test < 7 mm
• At least 2 symptoms of dry eye syndrome (foreign body sensation, burning, photophobia, blurred vision, pain, itching)
• Normal ophthalmic findings except dry eye syndrome

Exclusion Criteria:

• Regular use of medication (except contraceptives), abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
• Treatment in the previous 3 weeks with any drug
• Symptoms of a clinically relevant illness in the 3 weeks before the first study day
• Ametropia >= 6 Dpt
• Pregnancy
• Difference of more than 3 mm in Schirmer I test or difference of > 3 sec in BUT between the two eyes
• Known medical history of allergy, hypersensitivity or poor tolerance to any components of the medication or medical product used in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 30 healthy subjects; Subjects will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo	Device: GENTEAL HA® Eye Drops (NOVARTIS, Switzerland); Other: Physiological Sodium Chloride solution (0,9%); Placebo
EXPERIMENTAL: 30 patients with dry eye syndrome; Patients will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo	Device: GENTEAL HA® Eye Drops (NOVARTIS, Switzerland); Other: Physiological Sodium Chloride solution (0,9%); Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tear film thickness	change from baseline to 1 hour after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schirmer I Test	once on the study day	1 day
Tear Break Up Time	once on the study day	1 day
Ocular Surface Disease Index	once on the study day	1 day

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2014
• Study Completion (ANTICIPATED): February 1, 2015

Study Registration Dates

• First Submitted: December 7, 2012
• First Submitted That Met QC Criteria: December 17, 2012
• First Posted (ESTIMATE): December 20, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 14, 2014
• Last Update Submitted That Met QC Criteria: November 13, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: ocular surface disease index; tear film thickness; topical lubricants; Schirmer I test; break up time
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: OPHT-200612