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

August 31, 2015 updated by: Laboratoires Thea
Assess the patient feeling about the handiness of two different vials used to deliver both, unpreserved hyaluronic eye drops.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10787
        • Augenklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Thea

Collaborators

Axial Biotech, Inc

Investigators

  • Principal Investigator: Carl Erb, Augenklinik, Wittenbergplatz, Kleiststrasse 23-26, 10787 Berlin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 2, 2012

First Submitted That Met QC Criteria

March 2, 2012

First Posted (ESTIMATE)

March 7, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 2, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • LT1550-PIV-CE-10/11
  • 2012-001233-14 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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