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

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.
 
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

Tracking Information
First Submitted Date  ICMJE May 3, 2013
First Posted Date  ICMJE May 29, 2013
Last Update Posted Date November 27, 2013
Study Start Date  ICMJE May 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2013)
  • Tear Break Up Time [ Time Frame: change from screening to the last OCT measurement ]
    Total time frame is 14 days
  • 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.
  • Schirmer I test [ Time Frame: change from screening to after the last OCT measurement ]
    Total time frame is 14 days
  • Visual Acuity [ Time Frame: change from screening to after the last OCT measurement ]
    Total time frame is 14 days.
  • Intraocular Pressure [ Time Frame: change from screening to after the last OCT measurement ]
    Total time frame is 14 days
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Lachrymal Substitutes on Tear Film Thickness in Patients With Moderate Dry Eye Syndrome
Official Title  ICMJE Influence of Lachrymal Substitutes on Tear Film Thickness in Patients With Moderate Dry Eye Syndrome
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..

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye Syndrome
Intervention  ICMJE
  • Device: Thealoz Duo®
    Eye Drops
  • Device: Hyabak®
    Eye Drops
  • Device: Hydrabak®
    Eye Drops
Study Arms  ICMJE
  • Experimental: Dry Eye Syndrome I
    20 patients with moderate dry eye syndrome
    Intervention: Device: Thealoz Duo®
  • Active Comparator: Dry Eye Syndrome II
    20 patients with moderate dry eye syndrome
    Intervention: Device: Hyabak®
  • Active Comparator: Dry Eye Syndrome III
    20 patients with moderate dry eye syndrome
    Intervention: Device: Hydrabak®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01864330
Other Study ID Numbers  ICMJE OPHT-28102012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gerhard Garhofer, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gerhard Garhoefer, MD Department of Clinical Pharmacology, Medical University of Vienna
PRS Account Medical University of Vienna
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP