Correlation of Different Signs for Assessment of Dry Eye Syndrome

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Completed
• CT.gov ID: NCT01753687
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 2.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Other: Ocular scattering of the tear film; Other: Optical Coherence Tomography (OCT); Other: Measurement of tear film osmolarity	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Correlation of Different Signs for Assessment of Dry Eye Syndrome
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: 50 patients with dry eye syndrome	Other: Ocular scattering of the tear film; Other Names: OQAS, Visometrics, Spain ; Other: Optical Coherence Tomography (OCT); Tear film thickness as measured with OCT; Other: Measurement of tear film osmolarity; Other Names: TearLab®, OcuSens Inc, San Diego, USA

Outcome Measures

Primary Outcome Measures

1. Break up time [once on the study day]

   break up time of the tear film measured in seconds

2. Tear film thickness as measured with optical coherence tomography (OCT) [once on the study day]

   tear film thickness measured in micrometers

Secondary Outcome Measures

1. Visual Acuity [once on the study day]

   Total number of letters read using ETDRS Charts

2. Tear film osmolarity [once on the study day]

   Tear film osmolarity measured in mosmol/l

3. OSI (Objective Scattering Index) [once on the study day]

   The objective scattering index will be measured using the OQAS system (Visiometrics, Spain)

4. Staining of the cornea with fluorescein [once on the study day]

   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.

5. Impression cytology [once on the study day]

   After topical anesthesia of the eye, filter material is placed on the conjunctiva to obtain cytological samples, which will be prepared and evaluated.

6. Tear cytokines/chemokines [once on the study day]

   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.

7. Subjective symptoms of dry eye syndrome [once on the study day]

   a questionaire will be used

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Pharmacology, Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT01753687
• Other Study ID Numbers: OPHT-300511
• First Posted: Dec 20, 2012
• Last Update Posted: Nov 27, 2013
• Last Verified: Nov 1, 2013

• Keywords provided by Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna: break up time; tear film thickness; tear film osmolarity; objective scattering index; impression cytology; tear cytokines/chemokines; visual acuity; fluorescein staining
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome

Study Results

No Results Posted as of Nov 27, 2013