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

Primary Purpose

Dry Eye Syndrome

Status

Withdrawn

Phase

Phase 3

Locations

Austria

Study Type

Interventional

Intervention

GENTEAL HA® Eye Drops (NOVARTIS, Switzerland)

Physiological Sodium Chloride solution (0,9%)

About this trial

This is an interventional basic science trial for Dry Eye Syndrome focused on measuring topical lubricants, tear film thickness, break up time, ocular surface disease index, Schirmer I test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Clinical Pharmacology, Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

30 healthy subjects

30 patients with dry eye syndrome

Arm Description

Subjects will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo

Patients will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo

Outcomes

Primary Outcome Measures

Tear film thickness

Secondary Outcome Measures

Schirmer I Test

once on the study day

Tear Break Up Time

once on the study day

Ocular Surface Disease Index

once on the study day

Full Information

NCT ID

NCT01753596

First Posted

December 7, 2012

Last Updated

November 13, 2014

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT01753596

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Withdrawn

Study Start Date

December 2014 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Syndrome

Keywords

topical lubricants, tear film thickness, break up time, ocular surface disease index, Schirmer I test

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

30 healthy subjects

Arm Type

Experimental

Arm Description

Subjects will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo

Arm Title

30 patients with dry eye syndrome

Arm Type

Experimental

Arm Description

Patients will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo

Intervention Type

Device

Intervention Name(s)

GENTEAL HA® Eye Drops (NOVARTIS, Switzerland)

Intervention Type

Other

Intervention Name(s)

Physiological Sodium Chloride solution (0,9%)

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Tear film thickness

Time Frame

change from baseline to 1 hour after administration

Secondary Outcome Measure Information:

Title

Schirmer I Test

Description

once on the study day

Time Frame

1 day

Title

Tear Break Up Time

Description

once on the study day

Time Frame

1 day

Title

Ocular Surface Disease Index

Description

once on the study day

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Department of Clinical Pharmacology, Medical University of Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

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

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