Back to results

Influence of Lachrymal Substitutes on Tear Film Thickness in Patients With Moderate Dry Eye Syndrome

Primary Purpose

Dry Eye Syndrome

Status

Completed

Phase

Phase 4

Locations

Austria

Study Type

Interventional

Intervention

Thealoz Duo®

Hyabak®

Hydrabak®

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring topical lubricants, optical coherence tomography, tear break up time, Schirmer I test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men and women aged over 18 years
Signed and dated written informed consent.
History of dry eye syndrome for at least 3 months
Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm
OSDI (Ocular Surface Disease Index) ≤ 32 and ≥ 13
Normal ophthalmic findings except dry eye syndrome, ametropia < 6 Dpt.
No administration of topical lubricants 24 hours before the screening examination

Exclusion Criteria:

Participation in a clinical trial in the 3 weeks preceding the study
Symptoms of a clinically relevant illness in the 3 weeks before the first study day
Presence or history of a severe medical condition as judged by the clinical investigator
Intake of parasympathomimetic or anti-psychotic drugs
Wearing of contact lenses
Glaucoma
Treatment with corticosteroids in the 4 weeks preceding the study
Topical treatment with any ophthalmic drug except topical lubricants in the 4 weeks preceding the study
Ocular infection or clinically significant inflammation
Ocular surgery in the 3 months preceding the study
Sjögren's syndrome
Stevens-Johnson syndrome
History of allergic conjunctivitis
Ametropia >= 6 Dpt
Pregnancy, planned pregnancy or lactating
Known hypersensitivity to any component of the study medication.
Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease
Inability to understand the study procedures

Sites / Locations

Department of Clinical Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Dry Eye Syndrome I

Dry Eye Syndrome II

Dry Eye Syndrome III

Arm Description

20 patients with moderate dry eye syndrome

Outcomes

Primary Outcome Measures

Tear film thickness

Change in tear film thickness as measured with OCT. Total time frame is 4 hours

Secondary Outcome Measures

Tear Break Up Time

Total time frame is 14 days

Subjective evaluation of ocular comfort

Ocular comfort will be assessed immediately after instillation and at the end of the study day. Total time frame is 4 hours.

Schirmer I test

Total time frame is 14 days

Visual Acuity

Total time frame is 14 days.

Intraocular Pressure

Total time frame is 14 days

Full Information

NCT ID

NCT01864330

First Posted

May 3, 2013

Last Updated

November 26, 2013

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT01864330

Brief Title

Influence of Lachrymal Substitutes on Tear Film Thickness in Patients With Moderate Dry Eye Syndrome

Official Title

Influence of Lachrymal Substitutes on Tear Film Thickness in Patients With Moderate Dry Eye Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

September 2013 (Actual)

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 is a highly prevalent ocular disease with an increasing incidence in the elderly population. Topically administered lubricants are the basis for treatment of this disease. However, information about the corneal residence time of topical lubricants is still sparse, therefore no ideal treatment regimen has been found. Recently a new method for assessment of tear film thickness based on optical coherence tomography (OCT) has become available. The aim of the present study is to assess corneal residence time of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Hyabak® Eye Drops and Hydrabak® Eye Drops in patients with moderate dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test and determination of tear break up time (BUT) will be performed..

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, optical coherence tomography, tear break up time, Schirmer I test

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dry Eye Syndrome I

Arm Type

Experimental

Arm Description

20 patients with moderate dry eye syndrome

Arm Title

Dry Eye Syndrome II

Arm Type

Active Comparator

Arm Description

20 patients with moderate dry eye syndrome

Arm Title

Dry Eye Syndrome III

Arm Type

Active Comparator

Arm Description

20 patients with moderate dry eye syndrome

Intervention Type

Device

Intervention Name(s)

Thealoz Duo®

Intervention Description

Eye Drops

Intervention Type

Device

Intervention Name(s)

Hyabak®

Intervention Description

Eye Drops

Intervention Type

Device

Intervention Name(s)

Hydrabak®

Intervention Description

Eye Drops

Primary Outcome Measure Information:

Title

Tear film thickness

Description

Change in tear film thickness as measured with OCT. Total time frame is 4 hours

Time Frame

Change in tear film thickness from predose to 10 ± 3 minutes, 20 ± 3 minutes, 40 ± 5 minutes, 60 ± 5 minutes, 120 ± 10 minutes and 240 ± 10 minutes after instillation

Secondary Outcome Measure Information:

Title

Tear Break Up Time

Description

Total time frame is 14 days

Time Frame

change from screening to the last OCT measurement

Title

Subjective evaluation of ocular comfort

Description

Ocular comfort will be assessed immediately after instillation and at the end of the study day. Total time frame is 4 hours.

Time Frame

change after instillation and after the last OCT measurement

Title

Schirmer I test

Description

Total time frame is 14 days

Time Frame

change from screening to after the last OCT measurement

Title

Visual Acuity

Description

Total time frame is 14 days.

Time Frame

change from screening to after the last OCT measurement

Title

Intraocular Pressure

Description

Total time frame is 14 days

Time Frame

change from screening to after the last OCT measurement

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women aged over 18 years Signed and dated written informed consent. History of dry eye syndrome for at least 3 months Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm OSDI (Ocular Surface Disease Index) ≤ 32 and ≥ 13 Normal ophthalmic findings except dry eye syndrome, ametropia < 6 Dpt. No administration of topical lubricants 24 hours before the screening examination Exclusion Criteria: Participation in a clinical trial in the 3 weeks preceding the study Symptoms of a clinically relevant illness in the 3 weeks before the first study day Presence or history of a severe medical condition as judged by the clinical investigator Intake of parasympathomimetic or anti-psychotic drugs Wearing of contact lenses Glaucoma Treatment with corticosteroids in the 4 weeks preceding the study Topical treatment with any ophthalmic drug except topical lubricants in the 4 weeks preceding the study Ocular infection or clinically significant inflammation Ocular surgery in the 3 months preceding the study Sjögren's syndrome Stevens-Johnson syndrome History of allergic conjunctivitis Ametropia >= 6 Dpt Pregnancy, planned pregnancy or lactating Known hypersensitivity to any component of the study medication. Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease Inability to understand the study procedures

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerhard Garhoefer, MD

Organizational Affiliation

Department of Clinical Pharmacology, Medical University of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Clinical Pharmacology

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

Influence of Lachrymal Substitutes on Tear Film Thickness in Patients With Moderate Dry Eye Syndrome

We'll reach out to this number within 24 hrs