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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bitop AG
ClinicalTrials.gov Identifier:
NCT01684852
First received: September 11, 2012
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
Dry Eye Syndromes
 Other: Medical device, drug-like

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Eye Diseases
U.S. FDA Resources

Further study details as provided by Bitop AG:

Primary Outcome Measures:
  • Tear Break Up Time [ Time Frame: V1 and V2 ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: May 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684852

Locations
Germany
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
Investigators
Principal Investigator: Elisabeth Messmer, MD Augenklinik der LMU Klinikum der Universität München
  More Information

No publications provided

Responsible Party: Bitop AG
ClinicalTrials.gov Identifier: NCT01684852     History of Changes
Other Study ID Numbers: PPL-046, NIS BAT04
Study First Received: September 11, 2012
Last Updated: January 29, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bitop AG:
dry eye, sicca, HA, Hyaluronic Acid, ectoin, ectoine, bitop

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
 Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases

ClinicalTrials.gov processed this record on May 21, 2013