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Correlation of Different Signs for Assessment of Dry Eye Syndrome

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Ocular scattering of the tear film
Optical Coherence Tomography (OCT)
Measurement of tear film osmolarity
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dry Eye Syndrome focused on measuring break up time, tear film thickness, tear film osmolarity, objective scattering index, impression cytology, tear cytokines/chemokines, visual acuity, fluorescein staining

Eligibility Criteria

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

Inclusion Criteria:

  • Men and women aged over 18 years
  • History of dry eye syndrome for at least 3 months
  • At least 2 symptoms of dry eye syndrome (foreign body sensation, burning, photophobia, blurred vision, pain, itching) and/or tear break up time < 10 seconds
  • Normal ophthalmic findings except dry eye syndrome

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 that will interfere with the study aim as judged by the clinical investigator
  • Wearing of contact lenses
  • Intake of dietary supplements in the 3 months preceding the study
  • Glaucoma
  • Treatment with corticosteroids in the 4 weeks preceding the study
  • Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except topical lubricants
  • Ocular infection or clinically significant inflammation
  • Ocular surgery in the 3 months preceding the study
  • Sjögren's syndrome
  • Stevens-Johnson syndrome
  • Pregnancy, planned pregnancy or lactating

Sites / Locations

  • Department of Clinical Pharmacology, Medical University of Vienna

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

50 patients with dry eye syndrome

Arm Description

Outcomes

Primary Outcome Measures

Break up time
break up time of the tear film measured in seconds
Tear film thickness as measured with optical coherence tomography (OCT)
tear film thickness measured in micrometers

Secondary Outcome Measures

Visual Acuity
Total number of letters read using ETDRS Charts
Tear film osmolarity
Tear film osmolarity measured in mosmol/l
OSI (Objective Scattering Index)
The objective scattering index will be measured using the OQAS system (Visiometrics, Spain)
Staining of the cornea with fluorescein
The cornea will be divided into 5 regions (central, inferior, nasal, temporal, inferior) and each region will be graded from 0-4 in 0.5 steps as described in the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) study.
Impression cytology
After topical anesthesia of the eye, filter material is placed on the conjunctiva to obtain cytological samples, which will be prepared and evaluated.
Tear cytokines/chemokines
Samples of 40 µl tears will be taken with a glass capillary and stored in vials. The concentrations of several cytokines and chemokines will be evaluated.
Subjective symptoms of dry eye syndrome
a questionaire will be used

Full Information

First Posted
December 7, 2012
Last Updated
November 26, 2013
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01753687
Brief Title
Correlation of Different Signs for Assessment of Dry Eye Syndrome
Official Title
Correlation of Different Signs for Assessment of Dry Eye Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 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
No

5. Study Description

Brief Summary
Dry eye syndrome (DES) is a highly prevalent ocular condition inducing an inflammatory response of the ocular surface. Common symptoms include ocular discomfort, visual impairment and instability of the tear film with potential damage to the ocular surface. The rationale of the present study is to compare signs as assessed with new methods such as measurement of tear film thickness, tear film osmolarity and scattering of the tear film with well established methods for assessment of the severity of DES (Break up time, staining of the cornea with fluorescein). Additionally, impression cytology and determination of tear cytokines/chemokines will be performed to obtain information about inflammatory processes on the ocular surface.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
break up time, tear film thickness, tear film osmolarity, objective scattering index, impression cytology, tear cytokines/chemokines, visual acuity, fluorescein staining

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
50 patients with dry eye syndrome
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Ocular scattering of the tear film
Other Intervention Name(s)
OQAS, Visometrics, Spain
Intervention Type
Other
Intervention Name(s)
Optical Coherence Tomography (OCT)
Intervention Description
Tear film thickness as measured with OCT
Intervention Type
Other
Intervention Name(s)
Measurement of tear film osmolarity
Other Intervention Name(s)
TearLab®, OcuSens Inc, San Diego, USA
Primary Outcome Measure Information:
Title
Break up time
Description
break up time of the tear film measured in seconds
Time Frame
once on the study day
Title
Tear film thickness as measured with optical coherence tomography (OCT)
Description
tear film thickness measured in micrometers
Time Frame
once on the study day
Secondary Outcome Measure Information:
Title
Visual Acuity
Description
Total number of letters read using ETDRS Charts
Time Frame
once on the study day
Title
Tear film osmolarity
Description
Tear film osmolarity measured in mosmol/l
Time Frame
once on the study day
Title
OSI (Objective Scattering Index)
Description
The objective scattering index will be measured using the OQAS system (Visiometrics, Spain)
Time Frame
once on the study day
Title
Staining of the cornea with fluorescein
Description
The cornea will be divided into 5 regions (central, inferior, nasal, temporal, inferior) and each region will be graded from 0-4 in 0.5 steps as described in the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) study.
Time Frame
once on the study day
Title
Impression cytology
Description
After topical anesthesia of the eye, filter material is placed on the conjunctiva to obtain cytological samples, which will be prepared and evaluated.
Time Frame
once on the study day
Title
Tear cytokines/chemokines
Description
Samples of 40 µl tears will be taken with a glass capillary and stored in vials. The concentrations of several cytokines and chemokines will be evaluated.
Time Frame
once on the study day
Title
Subjective symptoms of dry eye syndrome
Description
a questionaire will be used
Time Frame
once on the study day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women aged over 18 years History of dry eye syndrome for at least 3 months At least 2 symptoms of dry eye syndrome (foreign body sensation, burning, photophobia, blurred vision, pain, itching) and/or tear break up time < 10 seconds Normal ophthalmic findings except dry eye syndrome 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 that will interfere with the study aim as judged by the clinical investigator Wearing of contact lenses Intake of dietary supplements in the 3 months preceding the study Glaucoma Treatment with corticosteroids in the 4 weeks preceding the study Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except topical lubricants Ocular infection or clinically significant inflammation Ocular surgery in the 3 months preceding the study Sjögren's syndrome Stevens-Johnson syndrome Pregnancy, planned pregnancy or lactating
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
25650419
Citation
Schmidl D, Witkowska KJ, Kaya S, Baar C, Faatz H, Nepp J, Unterhuber A, Werkmeister RM, Garhofer G, Schmetterer L. The association between subjective and objective parameters for the assessment of dry-eye syndrome. Invest Ophthalmol Vis Sci. 2015 Feb 3;56(3):1467-72. doi: 10.1167/iovs.14-15814.
Results Reference
derived

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Correlation of Different Signs for Assessment of Dry Eye Syndrome

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