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
  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: 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 ] [ 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.


Estimated Enrollment: 60
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546012

Contacts
Contact: Carl ERB carlerb.berlin2@yahoo.de

Locations
Germany
Augenklinik Not yet recruiting
Berlin, Germany, 10787
Contact: Carl Erb       carlerb.berlin2@yahoo.de   
Principal Investigator: Carl Erb, Professor         
Sub-Investigator: Zimmermann, Doctor         
Sponsors and Collaborators
Laboratoires Thea
AIXIAL
Investigators
Principal Investigator: Carl Erb Augenklinik, Wittenbergplatz, Kleiststrasse 23-26, 10787 Berlin
  More Information

No publications provided

Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT01546012     History of Changes
Other Study ID Numbers: LT1550-PIV-CE-10/11, 2012-001233-14
Study First Received: March 2, 2012
Last Updated: October 2, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on August 01, 2014