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Completed

NCT Number: NCT01684852

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

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.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Peter Otto, Bad Liebenwerda, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical device, drug-like

Other

Primary outcomes

  1. Tear Break Up Time

    Time frame: V1 and V2

Sponsors and collaborators

Lead sponsor

Bitop AG

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 13, 2012
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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