Clinical Trials Directory

Trials / Completed

CompletedNCT01684852

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
64 (actual)
Sponsor
Bitop AG · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERMedical device, drug-like

Timeline

Start date
2012-05-01
Primary completion
2012-11-01
Completion
2012-11-01
First posted
2012-09-13
Last updated
2026-01-29

Locations

5 sites across 1 country: Germany

Source: ClinicalTrials.gov record NCT01684852. Inclusion in this directory is not an endorsement.