We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01753596
First Posted: December 20, 2012
Last Update Posted: November 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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:


Further study details as provided by Gerhard Garhofer, Medical University of Vienna:

Primary Outcome Measures:
  • Tear film thickness [ Time Frame: change from baseline to 1 hour after administration ]

Secondary Outcome Measures:
  • Schirmer I Test [ Time Frame: 1 day ]
    once on the study day

  • Tear Break Up Time [ Time Frame: 1 day ]
    once on the study day

  • Ocular Surface Disease Index [ Time Frame: 1 day ]
    once on the study day


Enrollment: 0
Study Start Date: December 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753596


Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
  More Information

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
First Submitted: December 7, 2012
First Posted: December 20, 2012
Last Update Posted: November 14, 2014
Last Verified: November 2014

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

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