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

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01546012
• Other study ID #: LT1550-PIV-CE-10/11
• Secondary ID: 2012-001233-14
• Status: Withdrawn
• Phase: N/A
• First received: March 2, 2012
• Last updated: August 31, 2015

Study information

• Verified date: August 2015
• Source: Laboratoires Thea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

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

Intervention

Device:
• HYABAK®
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)

Locations

Country	Name	City	State
Germany	Augenklinik	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Laboratoires Thea	Axial Biotech, Inc

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No