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

Bitop

Status: Completed

Conditions: Dry Eye Syndromes

Treatments: Other: Medical device, drug-like

Study type: Observational

Funder types: Industry

Identifiers

NCT01684852

NIS BAT04

PPL-046

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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