Completed

Ectoin vs. HA Eye Drops for Dry Eye Disease Treatment

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Study Aim

This observational study aims to compare the effectiveness of Ectoin and HA eye drops in treating Dry Eye Disease by measuring the Tear Break Up Time.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Eye Diseases

+ Lacrimal Apparatus Diseases

+ Dry Eye Syndromes

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: May 2012
See protocol details

Summary

Principal SponsorBitop AG
Last updated: January 30, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2012

Actual date on which the first participant was enrolled.

This study focuses on evaluating the effectiveness and safety of an eye drop solution containing Ectoin, known as BAT04, in treating Dry Eye Disease. It compares BAT04 to another common treatment, Hyaluronic acid (HA) eye drops. The study is important as it aims to provide further evidence on the benefits and tolerability of BAT04 in managing Dry Eye Disease, a condition that affects many people worldwide. Participants in this study will use either BAT04 or HA eye drops as instructed, applying the drops six times a day in both eyes for a duration of 28 days. The study measures the response to treatment by recording the 'Tear Break Up Time' at the end of the 28-day period. This helps determine how well each treatment maintains the eye's tear film, which is crucial for eye comfort and vision clarity.

Official TitleNon 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
NCT01684852
Principal SponsorBitop AG
Last updated: January 30, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

64 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesLacrimal Apparatus DiseasesDry Eye Syndromes

Criteria

5 inclusion criteria required to participate
agreement to abide by the routinely provided doctor's appointment for follow-up (reflected in the planned visits of observation plan resist)
Demonstrated mild to moderate keratoconjunctivitis sicca ( "dry eye")
tear break-up time TBUT <10s
Acute symptoms of dry eye: DEWS 1-3
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6 exclusion criteria prevent from participating
patients with addictive disorders or substance abuse fallow in the past 12 months, as well as persons incapable of giving consent
Contact lens wearers
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

Dr. Peter Otto

Bad Liebenwerda, GermanyOpen Dr. Peter Otto in Google Maps
Suspended

Dr. Insa Beddermann

Duderstadt, Germany
Suspended

Augenklinik mit Poliklinik

Erlangen, Germany
Suspended

Augenklinik der LMU Klinikum der Universität Muenchen

München, Germany
Completed5 Study Centers