Assessment of Patient's Satisfaction Regarding the Handiness of Two Hyaluronic Acid Eye Drops Vials

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by Laboratoires Thea
Sponsor:
Collaborator:
AIXIAL
Information provided by (Responsible Party):
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01546012
First received: March 2, 2012
Last updated: October 2, 2012
Last verified: October 2012

March 2, 2012
October 2, 2012
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Overall preference of the patient [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
At Visit2: Week 6 +/- 1week: End of Study Visit. "Overall preference of the patient": number of answers Hyabak, Hylo-comod.
Same as current
Complete list of historical versions of study NCT01546012 on ClinicalTrials.gov Archive Site
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Assessment of Patient's Satisfaction Regarding the Handiness of Two Hyaluronic Acid Eye Drops Vials
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Assess the patient feeling about the handiness of two different vials used to deliver both, unpreserved hyaluronic eye drops.

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Interventional
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Assess the Patient Feeling About the Handiness of Two Different Vials Used to Deliver Both, Unpreserved Hyaluronic Eye Drops
  • Device: HYABAK®
    Hyaluronic Acid eye drops CE marked, packaged in multidose ABAK® container (preservative free)
  • Device: HYLO-COMOD®
    Hyaluronic Acid eye drops CE marked, packaged in multidose COMOD® container (preservative free)
  • Experimental: HYABAK®
    Hyaluronic Acid eye drops CE marked, packaged in multidose ABAK® container (preservative free)
    Intervention: Device: HYABAK®
  • Active Comparator: HYLO-COMOD®:
    Hyaluronic Acid eye drops CE marked, packaged in multidose COMOD® container (preservative free)
    Intervention: Device: HYLO-COMOD®
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
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Inclusion Criteria:

  • Man or woman aged 18 and older
  • Patient with dry eye for at least 3 months
  • Having given his written informed consent

Exclusion Criteria:

  • Intolerance to studied products
  • Patient's inability to understand the study procedures and give informed consent.
  • Patient unwilling to follow the study procedures and visits defined by the protocol.
  • Pregnant or lactating women.
  • Patient under guardian ship
Both
18 Years and older
No
Contact: Carl ERB carlerb.berlin2@yahoo.de
Germany
 
NCT01546012
LT1550-PIV-CE-10/11, 2012-001233-14
No
Laboratoires Thea
Laboratoires Thea
AIXIAL
Principal Investigator: Carl Erb Augenklinik, Wittenbergplatz, Kleiststrasse 23-26, 10787 Berlin
Laboratoires Thea
October 2012

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