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

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ClinicalTrials.gov Identifier: NCT01864330
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : November 27, 2013
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

Brief Summary:

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 or disease Intervention/treatment Phase
Dry Eye Syndrome Device: Thealoz Duo® Device: Hyabak® Device: Hydrabak® Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Lachrymal Substitutes on Tear Film Thickness in Patients With Moderate Dry Eye Syndrome
Study Start Date : May 2013
Primary Completion Date : August 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Tears
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

    Change in tear film thickness as measured with OCT.

    Total time frame is 4 hours



Secondary Outcome Measures :
  1. Tear Break Up Time [ Time Frame: change from screening to the last OCT measurement ]
    Total time frame is 14 days

  2. Subjective evaluation of ocular comfort [ Time Frame: change after instillation and after the last OCT measurement ]

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

    Total time frame is 4 hours.


  3. Schirmer I test [ Time Frame: change from screening to after the last OCT measurement ]
    Total time frame is 14 days

  4. Visual Acuity [ Time Frame: change from screening to after the last OCT measurement ]
    Total time frame is 14 days.

  5. Intraocular Pressure [ Time Frame: change from screening to after the last OCT measurement ]
    Total time frame is 14 days



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

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
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013

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

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