Dry Eye Syndromes
Conditions
Keywords
dry eye, sicca, HA, Hyaluronic Acid, ectoin, ectoine, bitop
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.
Interventions
Sponsors
Bitop AG
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tear Break Up Time | V1 and V2 |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORElisabeth Messmer, MD
Augenklinik der LMU Klinikum der Universität München
Outcome results
None listed