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This study has been withdrawn prior to enrollment.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:
Collaborator:
Axial Biotech, Inc
Information provided by (Responsible Party):
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01546012
First received: March 2, 2012
Last updated: August 31, 2015
Last verified: August 2015
  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.


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

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

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

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: August 31, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hyaluronic Acid
Ophthalmic Solutions
Adjuvants, Immunologic
Immunologic Factors
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Viscosupplements

ClinicalTrials.gov processed this record on February 04, 2016