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

This study has been withdrawn prior to enrollment.
(Too difficult to select patient according to the investigator)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01546012
First Posted: March 7, 2012
Last Update Posted: September 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Axial Biotech, Inc
Information provided by (Responsible Party):
Laboratoires Thea
March 2, 2012
March 7, 2012
September 2, 2015
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Overall preference of the patient [ Time Frame: 6 weeks ]
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: None (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.
 
Withdrawn
0
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01546012
LT1550-PIV-CE-10/11
2012-001233-14 ( EudraCT Number )
No
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Laboratoires Thea
Laboratoires Thea
Axial Biotech, Inc
Principal Investigator: Carl Erb Augenklinik, Wittenbergplatz, Kleiststrasse 23-26, 10787 Berlin
Laboratoires Thea
August 2015

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