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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This study has been withdrawn prior to enrollment.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
  Purpose
Assess the patient feeling about the handiness of two different vials used to deliver both, unpreserved hyaluronic eye drops.

Condition Intervention
Assess the Patient Feeling About the Handiness of Two Different Vials Used to Deliver Both, Unpreserved Hyaluronic Eye Drops Device: HYABAK® Device: HYLO-COMOD®

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)

Resource links provided by NLM:


Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • 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.


Enrollment: 0
Arms Assigned Interventions
Experimental: HYABAK®
Hyaluronic Acid eye drops CE marked, packaged in multidose ABAK® container (preservative free)
Device: HYABAK®
Hyaluronic Acid eye drops CE marked, packaged in multidose ABAK® container (preservative free)
Active Comparator: HYLO-COMOD®:
Hyaluronic Acid eye drops CE marked, packaged in multidose COMOD® container (preservative free)
Device: HYLO-COMOD®
Hyaluronic Acid eye drops CE marked, packaged in multidose COMOD® container (preservative free)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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): NCT01546012


Locations
Germany
Augenklinik
Berlin, Germany, 10787
Sponsors and Collaborators
Laboratoires Thea
Axial Biotech, Inc
Investigators
Principal Investigator: Carl Erb Augenklinik, Wittenbergplatz, Kleiststrasse 23-26, 10787 Berlin
  More Information

Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT01546012     History of Changes
Other Study ID Numbers: LT1550-PIV-CE-10/11
2012-001233-14 ( EudraCT Number )
First Submitted: March 2, 2012
First Posted: March 7, 2012
Last Update Posted: September 2, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Ophthalmic Solutions
Tetrahydrozoline
Hyaluronic Acid
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements
Protective Agents