Dry Eye SyndromesNCT01684852
Non Interventional Study to Evaluate the Efficacy and Tolerability of Ectoin Containing Ophthalmic Solution
An observational study of Dry Eye Syndromes, run by Bitop AG at 5 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Medical device, drug-like
- How many people
- 64 participants
- Where
- 5 sitesGermany
- Study dates
- May 2012to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Dr. Peter Otto
Bad Liebenwerda, 04924
Dr. Insa Beddermann
Duderstadt, 37115
Augenklinik mit Poliklinik
Erlangen, 91054
Augenklinik der LMU Klinikum der Universität Muenchen
München, 80336
Augenabteilung am St. Franziskus-Hospital Münster
Münster, 48145
About this study
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
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.
- Conditions
- Dry Eye Syndromes
- Being tested
- Medical device, drug-like
- Keywords
- dry eye, sicca, HA, Hyaluronic Acid, ectoin, ectoine, bitop
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical device, drug-likeOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Break Up Time
Measured: V1 and V2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitop AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabeth Messmer, MD, Principal investigator, Augenklinik der LMU Klinikum der Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684852
- Sponsor's protocol ID
- PPL-046
- Other IDs
- NIS BAT04
- Status last verified
- Jan 2026
- First submitted
- 11 Sep 2012
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01684852
- Acronym / sponsor ID
- PPL-046
- Conditions
- Dry Eye Syndromes
- Keywords
- dry eye, sicca, HA, Hyaluronic Acid, ectoin, ectoine, bitop
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 13 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical device, drug-like | Other | – |
Primary outcome
Tear Break Up Time
Time frame: V1 and V2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Messmer, MD principal investigator
Augenklinik der LMU Klinikum der Universität München
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Syndromes, run by Bitop AG at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear Break Up Time (time frame: V1 and V2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.