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

Completed

• Conditions: Dry Eye Syndromes

• Registration Number: NCT01684852
• Lead Sponsor: Bitop AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2012-09-11
• Study First Posted: 2012-09-13
• Primary Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-29
• Last Update Posted: 2013-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tear Break Up Time	V1 and V2

Trial Locations

Locations (5)

Dr. Peter Otto; 🇩🇪 Bad Liebenwerda, Germany

Augenklinik der LMU Klinikum der Universität Muenchen; 🇩🇪 Muenchen, Germany

Augenklinik mit Poliklinik; 🇩🇪 Erlangen, Germany

Dr. Insa Beddermann; 🇩🇪 Duderstadt, Germany

Augenabteilung am St. Franziskus-Hospital Münster; 🇩🇪 Muenster, Germany