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Completed

NCT Number: NCT03161080

Effect of Single Instillation of Three Different Topical Lubricants on Tear Film Thickness in Patients With Dry Eye Syndrome

The prevalence and incidence of dry eye syndrome (DES) is constantly increasing. Several therapeutic strategies have been proposed, but still no ideal regimen has been found. Recently, a new method for the non- invasive measurement of tear film thickness (TFT) based on optical coherence tomography (OCT) has been developed. It has been shown in previous studies that TFT correlates well with objective signs as well as with subjective symptoms of DES.

In the present study the effects of three different topical lubricants (Neovis total multi®, Vismed multi® and Hydrabak® eye drops) on tear film thickness in patients with moderate to severe DES will be investigated using this device.

Tear film thickness will be measured at baseline and at defined time points after single instillation. The course of tear film thickness during this study day will provide information about the corneal residency time of the three different eye drops. Patients with moderate to severe DES will be randomized to receive either Neovis total multi®, Vismed multi® or Hydrabak® eye drops. Assessment of lipid layer thickness of the tear film will be performed before and at pre-specified time points after instillation as secondary outcome.

Other clinical measures for DES such as determination of tear film break up time (TFBUT), corneal fluorescein staining, Schirmer I test and subjective assessments will also be performed.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients will be eligible for inclusion if all these criteria are respected:

  • Age of at least 18 years
  • Provides written informed consent prior to study-related procedures at the screening visit
  • Is able to understand and willing to comply with the procedures and the actions asked of him/her
  • History of dry eye syndrome for at least 3 months
  • Reports at least 2 of the following symptoms related to dry eye syndrome: foreign body sensation, pain, itching, stinging, epiphora, photophobia or blurred vision
  • Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 10 mm
  • OSDI score ≥ 23 points
  • Normal ophthalmic findings except dry eye syndrome

Exclusion criteria

Patients will be excluded under the following circumstances:

  • 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 in the medical history
  • 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 not related to dry eye syndrome
  • Ocular surgery in the 3 months preceding the study
  • Sjögren's syndrome
  • Stevens-Johnson syndrome
  • History of allergic conjunctivitis
  • Pregnancy, planned pregnancy or lactating
  • Known hypersensitivity to any component of the study medication

Treatment and study plan

Neovis Total Multi® Eye Drops

Device

Eye Drops containing Sodium hyaluronate (0.18%), lipoic acid, hydroxypropyl methylcellulose

Vismed Multi® Eye Drops

Device

Eye Drops containing Sodium hyaluronate (0.18%), potassium chloride, disodium phosphate

Hydrabak® Eye Drops

Device

Eye Drops containing sodium chloride (0,9%), sodium dihydrogen phosphate dehydrate

Primary outcomes

  1. Change in tear film thickness

    Time frame: 1 day

    Change in tear film thickness measured with optical coherence tomography (OCT) at predose and at defined time points after instillation of eyedrops

Secondary outcomes

  1. Change in lipid layer thickness

    Time frame: 1 day

    Change in lipid layer thickness measured with the LipiViewII Ocular Surface Interferometer at predose and at defined time points after instillation of eyedrops

  2. Tear Break Up Time (TBUT)

    Time frame: 2 weeks

    Tear Break Up Time measured at screening visit and on study day

  3. Visual Analogue Scale (VAS)

    Time frame: 2 weeks

    Visual Analogue Scale about dry eye symptoms at screening visit and on study day

  4. Schirmer I test

    Time frame: 2 weeks

    Schirmer I test measured at screening visit and on study

  5. Ocular Surface Disease Index (OSDI) score

    Time frame: 1 day

    Ocular Surface Disease Index (OSDI) score assessed with questionnaire at screening visit

  6. Corneal fluorescein staining

    Time frame: 2 weeks

    Corneal fluorescein staining at screening visit and on study day

  7. Visual acuity

    Time frame: 2 weeks

    Visual acuity assessed at screening visit and on study day

  8. Intraocular pressure (IOP)

    Time frame: 1 day

    Intraocular pressure measured at screening visit

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 19, 2017
Registry last updated
Aug 22, 2019

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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