Influence of Lachrymal Substitutes on Tear Film Thickness in Patients With Moderate Dry Eye Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01864330
First received: May 3, 2013
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

Dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the elderly population. Topically administered lubricants are the basis for treatment of this disease. However, information about the corneal residence time of topical lubricants is still sparse, therefore no ideal treatment regimen has been found.

Recently a new method for assessment of tear film thickness based on optical coherence tomography (OCT) has become available. The aim of the present study is to assess corneal residence time of three different formulations of topical lubricants, in particular Thealoz Duo® Eye Drops, Hyabak® Eye Drops and Hydrabak® Eye Drops in patients with moderate dry eye disease. In addition, standard tests for dry eye syndrome, such as the ocular surface disease index (OSDI©), Schirmer I test and determination of tear break up time (BUT) will be performed..


Condition Intervention Phase
Dry Eye Syndrome
Device: Thealoz Duo®
Device: Hyabak®
Device: Hydrabak®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Lachrymal Substitutes on Tear Film Thickness in Patients With Moderate Dry Eye Syndrome

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Tear film thickness [ Time Frame: Change in tear film thickness from predose to 10 ± 3 minutes, 20 ± 3 minutes, 40 ± 5 minutes, 60 ± 5 minutes, 120 ± 10 minutes and 240 ± 10 minutes after instillation ] [ Designated as safety issue: No ]

    Change in tear film thickness as measured with OCT.

    Total time frame is 4 hours



Secondary Outcome Measures:
  • Tear Break Up Time [ Time Frame: change from screening to the last OCT measurement ] [ Designated as safety issue: No ]
    Total time frame is 14 days

  • Subjective evaluation of ocular comfort [ Time Frame: change after instillation and after the last OCT measurement ] [ Designated as safety issue: No ]

    Ocular comfort will be assessed immediately after instillation and at the end of the study day.

    Total time frame is 4 hours.


  • Schirmer I test [ Time Frame: change from screening to after the last OCT measurement ] [ Designated as safety issue: No ]
    Total time frame is 14 days

  • Visual Acuity [ Time Frame: change from screening to after the last OCT measurement ] [ Designated as safety issue: No ]
    Total time frame is 14 days.

  • Intraocular Pressure [ Time Frame: change from screening to after the last OCT measurement ] [ Designated as safety issue: No ]
    Total time frame is 14 days


Enrollment: 60
Study Start Date: May 2013
Study Completion Date: September 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dry Eye Syndrome I
20 patients with moderate dry eye syndrome
Device: Thealoz Duo®
Eye Drops
Active Comparator: Dry Eye Syndrome II
20 patients with moderate dry eye syndrome
Device: Hyabak®
Eye Drops
Active Comparator: Dry Eye Syndrome III
20 patients with moderate dry eye syndrome
Device: Hydrabak®
Eye Drops

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged over 18 years
  • Signed and dated written informed consent.
  • History of dry eye syndrome for at least 3 months
  • Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 5 mm and ≥ 2mm
  • OSDI (Ocular Surface Disease Index) ≤ 32 and ≥ 13
  • Normal ophthalmic findings except dry eye syndrome, ametropia < 6 Dpt.
  • No administration of topical lubricants 24 hours before the screening examination

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 as judged by the clinical investigator
  • Intake of parasympathomimetic or anti-psychotic drugs
  • Wearing of contact lenses
  • Glaucoma
  • Treatment with corticosteroids in the 4 weeks preceding the study
  • Topical treatment with any ophthalmic drug except topical lubricants in the 4 weeks preceding the study
  • Ocular infection or clinically significant inflammation
  • Ocular surgery in the 3 months preceding the study
  • Sjögren's syndrome
  • Stevens-Johnson syndrome
  • History of allergic conjunctivitis
  • Ametropia >= 6 Dpt
  • Pregnancy, planned pregnancy or lactating
  • Known hypersensitivity to any component of the study medication.
  • Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease
  • Inability to understand the study procedures
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01864330

Locations
Austria
Department of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Gerhard Garhoefer, MD Department of Clinical Pharmacology, Medical University of Vienna
  More Information

No publications provided

Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01864330     History of Changes
Other Study ID Numbers: OPHT-28102012
Study First Received: May 3, 2013
Last Updated: November 26, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Medical University of Vienna:
topical lubricants
optical coherence tomography
tear break up time
Schirmer I test

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases

ClinicalTrials.gov processed this record on July 23, 2014