NCT01546012

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
Last Updated

September 2, 2015

Status Verified

August 1, 2015

First QC Date

March 2, 2012

Last Update Submit

August 31, 2015

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Overall preference of the patient

    At Visit2: Week 6 +/- 1week: End of Study Visit. "Overall preference of the patient": number of answers Hyabak, Hylo-comod.

    6 weeks

Study Arms (2)

HYABAK®

EXPERIMENTAL

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

Device: HYABAK®

HYLO-COMOD®:

ACTIVE COMPARATOR

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

Device: HYLO-COMOD®

Interventions

HYABAK®DEVICE

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

HYABAK®
HYLO-COMOD®DEVICE

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

HYLO-COMOD®:

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Man or woman aged 18 and older
  • Patient with dry eye for at least 3 months
  • Having given his written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augenklinik

Berlin, 10787, Germany

Location

Study Officials

  • Carl Erb

    Augenklinik, Wittenbergplatz, Kleiststrasse 23-26, 10787 Berlin

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2012

First Posted

March 7, 2012

Last Updated

September 2, 2015

Record last verified: 2015-08

Locations

DE(1)