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

Phase 3

Withdrawn

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

• Registration Number: NCT01753596
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-20
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-14
• Study Start: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30 patients with dry eye syndrome	GENTEAL HA® Eye Drops (NOVARTIS, Switzerland)	Patients will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo
30 healthy subjects	Physiological Sodium Chloride solution (0,9%)	Subjects will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo
30 healthy subjects	GENTEAL HA® Eye Drops (NOVARTIS, Switzerland)	Subjects will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo
30 patients with dry eye syndrome	Physiological Sodium Chloride solution (0,9%)	Patients will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo

Primary Outcome Measures

Name	Time	Method
Tear film thickness	change from baseline to 1 hour after administration

Secondary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index	1 day	once on the study day
Schirmer I Test	1 day	once on the study day
Tear Break Up Time	1 day	once on the study day

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria