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

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ClinicalTrials.gov Identifier: NCT03161080
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Device: Neovis Total Multi® Eye Drops Device: Vismed Multi® Eye Drops Device: Hydrabak® Eye Drops Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Single Instillation of Three Different Topical Lubricants on Tear Film Thickness in Patients With Dry Eye Syndrome
Actual Study Start Date : February 9, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Dry Eye Neovis
20 Patients with dry eye syndrome receiving Neovis Total Multi Eyedrops
Device: Neovis Total Multi® Eye Drops
Eye Drops containing Sodium hyaluronate (0.18%), lipoic acid, hydroxypropyl methylcellulose

Experimental: Dry Eye Vismed
20 Patients with dry eye syndrome receiving Vismed Multi Eyedrops
Device: Vismed Multi® Eye Drops
Eye Drops containing Sodium hyaluronate (0.18%), potassium chloride, disodium phosphate

Experimental: Dry Eye Hydrabak
20 Patients with dry eye syndrome receiving Hydrabak Eyedrops
Device: Hydrabak® Eye Drops
Eye Drops containing sodium chloride (0,9%), sodium dihydrogen phosphate dehydrate




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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

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

Exclusion Criteria

Patients will be excluded under the following circumstances:

  1. Participation in a clinical trial in the 3 weeks preceding the study
  2. Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  3. Presence or history of a severe medical condition as judged by the clinical investigator
  4. Intake of parasympathomimetic or anti-psychotic drugs
  5. Wearing of contact lenses
  6. Glaucoma in the medical history
  7. Treatment with corticosteroids in the 4 weeks preceding the study
  8. Topical treatment with any ophthalmic drug except topical lubricants in the 4 weeks preceding the study
  9. Ocular infection or clinically significant inflammation not related to dry eye syndrome
  10. Ocular surgery in the 3 months preceding the study
  11. Sjögren's syndrome
  12. Stevens-Johnson syndrome
  13. History of allergic conjunctivitis
  14. Pregnancy, planned pregnancy or lactating
  15. Known hypersensitivity to any component of the study medication

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): NCT03161080


Contacts
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Contact: Gerhard Garhoefer, MD +43 1 40400 ext 29810 gerhard.garhoefer@meduniwien.ac.at
Contact: Doreen Schmidl, MD, PhD +43 1 40400 ext 29810 doreen.schmidl@meduniwien.ac.at

Locations
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Austria
Department of Clinical Pharmacology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Gerhard Garhoefer, MD    +43 1 40400 ext 29810    gerhard.garhoefer@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03161080     History of Changes
Other Study ID Numbers: OPHT-250716
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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