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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01684852
Recruitment Status : Completed
First Posted : September 13, 2012
Last Update Posted : January 30, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Dry Eye Syndromes Other: Medical device, drug-like

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Study Type : Observational
Actual Enrollment : 64 participants
Observational Model: Case Control
Time Perspective: Prospective
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
Study Start Date : May 2012
Actual Primary Completion Date : December 2012

Primary Outcome Measures :
  1. Tear Break Up Time [ Time Frame: V1 and V2 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01684852

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Dr. Peter Otto
Bad Liebenwerda, Germany, 04924
Dr. Insa Beddermann
Duderstadt, Germany, 37115
Augenklinik mit Poliklinik
Erlangen, Germany, 91054
Augenklinik der LMU Klinikum der Universität Muenchen
Muenchen, Germany, 80336
Augenabteilung am St. Franziskus-Hospital Münster
Muenster, Germany, 48145
Sponsors and Collaborators
Bitop AG
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Principal Investigator: Elisabeth Messmer, MD Augenklinik der LMU Klinikum der Universität München

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Responsible Party: Bitop AG Identifier: NCT01684852    
Other Study ID Numbers: PPL-046
First Posted: September 13, 2012    Key Record Dates
Last Update Posted: January 30, 2013
Last Verified: January 2013
Keywords provided by Bitop AG:
dry eye, sicca, HA, Hyaluronic Acid, ectoin, ectoine, bitop
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions