Trial document




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  DRKS00009764

Trial Description

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Title

Effect of Ocuvers Spray Hyaluron on Tear Film and Ocular Comfort

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

80% of dry eye is caused by an abnormal lipid layer.
The liposomal eye Spray LipoNit® is well-accepted in dry eye treatment since it is able to improve the lipid layer. The lipid layer protects the tear film against evaporation. Different studies were able to show the improvement of the lipid layer and tear film stability and dry eye symptoms.
A new spray was launched, named Ocuvers Spray Hyaluron being able to build up the lipid layer of the tear film and to stabilize the tear film and to reduce evaporation of the tear film.

Ocuvers Spray Hyaluron is claimed to regulate and optimize wetting of the ocular surface.

Aim of this pilot study is to measure this effect of Ocuvers Spray Hyaluron by observing the lipidlayer and the tear film stability, vision and subjective comfort will be analysed over a period of 90min in healthy subjects.

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Brief Summary in Scientific Language

80% of dry eye is caused by an abnormal lipid layer.
The liposomal eye Spray LipoNit® is well-accepted in dry eye treatment since it is able to improve the lipid layer. Different studies were able to show the improvement of the lipid layer and tear film stability and dry eye symptoms.
A new spray was launched, named Ocuvers Spray Hyaluron being able to build up the lipid layer of the tear film and to stabilize the tear film and to reduce evaporation of the tear film.

Ocuvers Spray Hyaluron is claimed to regulate and optimize wettin gof the ocular surface.

Aim of this pilot study is to measure this effect of Ocuvers Spray Hyaluron by observing the lipidlayer and the tear film stability, vision and subjective comfort will be analysed over a period of 90min in healthy subjects.

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Organizational Data

  •   DRKS00009764
  •   2015/12/07
  •   [---]*
  •   no
  •   Approved
  •   015/1679, Freibuger Ethik Kommission FEKI
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Observation of the tear film (in healthy volunteers)
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Interventions/Observational Groups

  •   Effect of the Ocuvers Srpay Hyaluron on the tear film after a single use of the spray. Application as described by the manufacturer: 2x spraying in 10cm distance to the eye
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Lipid layer interference pattern: Observed by tearscope (Keeler) before application and after application at 10min, 30min, 60min, 90min

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Secondary Outcome

tear film stability. Observed by tearscope (Keeler) before application and after application at 10min, 30min, 60min, 90min

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2015/12/07
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

healthy subjects

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Exclusion Criteria

Contact lens wearer (except lenses removed prior to study) younger than 18years; subjects with ocular defects, degeneration, inflammation; being pregnant, use of artificial tears or ocular medication at day of observation

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Addresses

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    • Kroll Medical GmbH, Wang, Deutschland
    • Mr.  Michael  Kroll 
    • Wittibsmühle 5
    • 85361  Moosburg/Wang
    • Germany
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    • Dr Heiko Pult - Optometry and Vision Research
    • Mr.  Dr  Heiko  Pult 
    • Steingasse 15
    • 69469  Weinheim
    • Germany
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    • Dr Heiko Pult - Optometry and Vision Research
    • Mr.  Dr  Heiko  Pult 
    • Steingasse 15
    • 69469  Weinheim
    • Germany
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Sources of Monetary or Material Support

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    • Kroll Medical GmbH, Wang, Deutschland
    • Mr.  Michael  Kroll 
    • Wittibsmühle 5
    • 85361  Moosburg/Wang
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/02/29
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.