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

This study is not yet open for participant recruitment.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 2, 2012

Last Updated Date

October 2, 2012

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01546012 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

Brief Summary

Assess the patient feeling about the handiness of two different vials used to deliver both, unpreserved hyaluronic eye drops.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label

Condition ^ICMJE

Assess the Patient Feeling About the Handiness of Two Different Vials Used to Deliver Both, Unpreserved Hyaluronic Eye Drops

Intervention ^ICMJE

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)

Study Arm (s)

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®

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Carl ERB

carlerb.berlin2@yahoo.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01546012

Other Study ID Numbers ^ICMJE

LT1550-PIV-CE-10/11, 2012-001233-14

Has Data Monitoring Committee

Responsible Party

Laboratoires Thea

Study Sponsor ^ICMJE

Laboratoires Thea

Collaborators ^ICMJE

AIXIAL

Investigators ^ICMJE

Principal Investigator:

Carl Erb

Augenklinik, Wittenbergplatz, Kleiststrasse 23-26, 10787 Berlin

Information Provided By

Laboratoires Thea

Verification Date

October 2012

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

To Top