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

Sponsor

Medical University of Vienna (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01753596

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Device: GENTEAL HA® Eye Drops (NOVARTIS, Switzerland) Other: Physiological Sodium Chloride solution (0,9%)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Dec 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Feb 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Tear film thickness [change from baseline to 1 hour after administration]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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