Non Interventional Study to Evaluate the Efficacy and Tolerability of Ectoin Containing Ophthalmic Solution

Dry Eye Syndromes Clinical Trial

Official title:

Non Interventional Study to Evaluate the Efficacy and Tolerability of Ectoin Containing Ophthalmic Solution (BAT04) Compared to HA Eye Drops in the Treatment of Dry Eye Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684852
• Other study ID #: PPL-046
• Secondary ID: NIS BAT04
• Status: Completed
• Phase: N/A
• First received: September 11, 2012
• Last updated: January 29, 2013
• Start date: May 2012

Study information

• Verified date: January 2013
• Source: Bitop AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

This is a comparative, open label, parallel group, non interventional study to further demonstrate the efficacy and tolerability of BAT04. In addition the efficacy and safety shall be compared to Hyaluronic acid (HA)-Product. The patient applies BAT04 or HA-Product according to the instructions for use six times daily in both eyes over a period of 28 days. Response to treatment is recorded at day 28.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female person aged 18 years

• Demonstrated mild to moderate keratoconjunctivitis sicca ( "dry eye")

• Acute symptoms of dry eye: DEWS 1-3

• tear break-up time TBUT <10s

• agreement to abide by the routinely provided doctor's appointment for follow-up (reflected in the planned visits of observation plan resist)

Exclusion Criteria:

• inflammation of the anterior segment or trauma

• Contact lens wearers

• Any disease that can, in the opinion of the treating physician to affect the outcome of the study.

• Patients with known intolerance to one of the substances used

• Surgical procedures to the eyes in the last 6 weeks before inclusion in the trial

• patients with addictive disorders or substance abuse fallow in the past 12 months, as well as persons incapable of giving consent

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Other:
• Medical device, drug-like

Locations

Country	Name	City	State
Germany	Dr. Peter Otto	Bad Liebenwerda
Germany	Dr. Insa Beddermann	Duderstadt
Germany	Augenklinik mit Poliklinik	Erlangen
Germany	Augenklinik der LMU Klinikum der Universität Muenchen	Muenchen
Germany	Augenabteilung am St. Franziskus-Hospital Münster	Muenster

Sponsors (1)

Lead Sponsor	Collaborator
Bitop AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear Break Up Time		V1 and V2	No