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Completed

NCT Number: NCT01864330

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

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..

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Clinical Pharmacology

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thealoz Duo®

Device

Eye Drops

Hyabak®

Device

Eye Drops

Hydrabak®

Device

Eye Drops

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 29, 2013
Registry last updated
Nov 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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