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

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Other: Medical device, drug-like

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• Germany
  • Bad Liebenwerda, Germany, 04924
    • Dr. Peter Otto
  • Duderstadt, Germany, 37115
    • Dr. Insa Beddermann
  • Erlangen, Germany, 91054
    • Augenklinik mit Poliklinik
  • München, Germany, 80336
    • Augenklinik der LMU Klinikum der Universität Muenchen
  • Münster, Germany, 48145
    • Augenabteilung am St. Franziskus-Hospital Münster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic The selection of appropriate patients for the observational study is made by the individual physician in his treatment decisions in consultation with the individual patient

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tear Break Up Time	V1 and V2

Collaborators and Investigators

• Sponsor: Bitop AG
• Investigators: Principal Investigator: Elisabeth Messmer, MD, Augenklinik der LMU Klinikum der Universität München

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: September 11, 2012
• First Submitted That Met QC Criteria: September 11, 2012
• First Posted (Estimated): September 13, 2012

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: dry eye, sicca, HA, Hyaluronic Acid, ectoin, ectoine, bitop
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Equipment and Supplies
• Other Study ID Numbers: PPL-046; NIS BAT04