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

This study is not yet open for participant recruitment.
Verified December 2012 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01753596
First received: December 7, 2012
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Dry Eye Syndrome
 Device: GENTEAL HA® Eye Drops (NOVARTIS, Switzerland)
Other: Physiological Sodium Chloride solution (0,9%)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Assessment of Tear Film Thickness by Optical Coherence Tomography in Healthy Subjects and Subjects With Dry Eye Disease

Resource links provided by NLM:

MedlinePlus related topics: Eye Diseases
U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Tear film thickness [ Time Frame: change from baseline to 1 hour after administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Schirmer I Test [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    once on the study day

  • Tear Break Up Time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    once on the study day

  • Ocular Surface Disease Index [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    once on the study day


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 30 healthy subjects
Subjects will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo
 Device: GENTEAL HA® Eye Drops (NOVARTIS, Switzerland) Other: Physiological Sodium Chloride solution (0,9%)
Placebo
Experimental: 30 patients with dry eye syndrome
Patients will receive 1 drop of Genteal HA eye drops in one randomly chosen eye, the other eye will receive placebo
 Device: GENTEAL HA® Eye Drops (NOVARTIS, Switzerland) Other: Physiological Sodium Chloride solution (0,9%)
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753596

Contacts
Contact: Gerhard Garhoefer, MD +43140400 ext 2981 gerhard.garhoefer@meduniwien.ac.at

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna Not yet recruiting
Vienna, Austria, 1090
Contact: Gerhard Garhoefer, MD     +43140400 ext 2981     gerhard.garhoefer@meduniwien.ac.at    
Principal Investigator: Gerhard Garhoefer, MD            
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01753596     History of Changes
Other Study ID Numbers: OPHT-200612
Study First Received: December 7, 2012
Last Updated: December 17, 2012
Health Authority: Austria: Austrian Medicines and Medical Devices Agency

Keywords provided by Medical University of Vienna:
topical lubricants
tear film thickness
break up time
ocular surface disease index
Schirmer I test

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Tetrahydrozoline
 Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013