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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This study has been withdrawn prior to enrollment.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)
Axial Biotech, Inc
Information provided by (Responsible Party):
Laboratoires Thea Identifier:
First received: March 2, 2012
Last updated: August 31, 2015
Last verified: August 2015
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®

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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)
Hyaluronic Acid eye drops CE marked, packaged in multidose COMOD® container (preservative free)


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

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
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Please refer to this study by its identifier: NCT01546012

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

Responsible Party: Laboratoires Thea Identifier: NCT01546012     History of Changes
Other Study ID Numbers: LT1550-PIV-CE-10/11
2012-001233-14 ( EudraCT Number )
Study First Received: March 2, 2012
Last Updated: August 31, 2015

Additional relevant MeSH terms:
Hyaluronic Acid
Ophthalmic Solutions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents processed this record on May 22, 2017