NCT01753687

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 20, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

1.8 years

First QC Date

December 7, 2012

Last Update Submit

November 26, 2013

Conditions

Dry Eye Syndrome

Keywords

break up timetear film thicknesstear film osmolarityobjective scattering indeximpression cytologytear cytokines/chemokinesvisual acuityfluorescein staining

Outcome Measures

Primary Outcomes (2)

  • Break up time

    break up time of the tear film measured in seconds

    once on the study day

  • Tear film thickness as measured with optical coherence tomography (OCT)

    tear film thickness measured in micrometers

    once on the study day

Secondary Outcomes (7)

  • Visual Acuity

    once on the study day

  • Tear film osmolarity

    once on the study day

  • OSI (Objective Scattering Index)

    once on the study day

  • Staining of the cornea with fluorescein

    once on the study day

  • Impression cytology

    once on the study day

  • +2 more secondary outcomes

Study Arms (1)

50 patients with dry eye syndrome

OTHER
Other: Ocular scattering of the tear filmOther: Optical Coherence Tomography (OCT)Other: Measurement of tear film osmolarity

Interventions

Ocular scattering of the tear filmOTHER
Also known as: OQAS, Visometrics, Spain
50 patients with dry eye syndrome
Optical Coherence Tomography (OCT)OTHER

Tear film thickness as measured with OCT

50 patients with dry eye syndrome
Measurement of tear film osmolarityOTHER
Also known as: TearLab®, OcuSens Inc, San Diego, USA
50 patients with dry eye syndrome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

  • 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.

    PMID: 25650419DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. PD Dr.

Study Record Dates

First Submitted

December 7, 2012

First Posted

December 20, 2012

Study Start

September 1, 2011

Primary Completion

July 1, 2013

Study Completion

September 1, 2013

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations

AU(1)