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

NCT ID: NCT01546012

Last Updated: 2015-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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HYABAK®

Hyaluronic Acid eye drops CE marked, packaged in multidose ABAK® container (preservative free)

Group Type EXPERIMENTAL

HYABAK®

Intervention Type DEVICE

Hyaluronic Acid eye drops CE marked, packaged in multidose ABAK® container (preservative free)

HYLO-COMOD®:

Hyaluronic Acid eye drops CE marked, packaged in multidose COMOD® container (preservative free)

Group Type ACTIVE_COMPARATOR

HYLO-COMOD®

Intervention Type DEVICE

Hyaluronic Acid eye drops CE marked, packaged in multidose COMOD® container (preservative free)

Interventions

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HYABAK®

Hyaluronic Acid eye drops CE marked, packaged in multidose ABAK® container (preservative free)

Intervention Type DEVICE

HYLO-COMOD®

Hyaluronic Acid eye drops CE marked, packaged in multidose COMOD® container (preservative free)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Axial Biotech, Inc

INDUSTRY

Sponsor Role collaborator

Laboratoires Thea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carl Erb

Role: PRINCIPAL_INVESTIGATOR

Augenklinik, Wittenbergplatz, Kleiststrasse 23-26, 10787 Berlin

Locations

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Augenklinik

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2012-001233-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LT1550-PIV-CE-10/11

Identifier Type: -

Identifier Source: org_study_id

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