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

Dry Eye Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01753596
• Other study ID #: OPHT-200612
• Status: Withdrawn
• Phase: Phase 3
• First received: December 7, 2012
• Last updated: November 13, 2014
• Start date: December 2014
• Est. completion date: February 2015

Study information

• Verified date: November 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

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

Intervention

Device:
• GENTEAL HA® Eye Drops (NOVARTIS, Switzerland)

Other:
• Physiological Sodium Chloride solution (0,9%)
Placebo

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	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 from baseline to 1 hour after administration	No
Secondary	Schirmer I Test	once on the study day	1 day	No
Secondary	Tear Break Up Time	once on the study day	1 day	No
Secondary	Ocular Surface Disease Index	once on the study day	1 day	No