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

NCT01684852 | Completed

• 2 other identifiers: PPL-046NIS BAT04
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 5

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.

Conditions

Dry Eye Syndromes

Keywords

dry eye, sicca, HA, Hyaluronic Acid, ectoin, ectoine, bitop

Outcome Measures

Primary Outcomes (1)

• Tear Break Up Time

  V1 and V2

Interventions

Medical device, drug-like OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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
• patients with addictive disorders or substance abuse fallow in the past 12 months, as well as persons incapable of giving consent

Sponsors & Collaborators

• Bitop AG: lead

Study Sites (5)

Dr. Peter Otto

Bad Liebenwerda, 04924, Germany

Location

Dr. Insa Beddermann

Duderstadt, 37115, Germany

Location

Augenklinik mit Poliklinik

Erlangen, 91054, Germany

Location

Augenklinik der LMU Klinikum der Universität Muenchen

München, 80336, Germany

Location

Augenabteilung am St. Franziskus-Hospital Münster

Münster, 48145, Germany

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Elisabeth Messmer, MD

  Augenklinik der LMU Klinikum der Universität München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 13, 2012
• Study Start: May 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

DE (5)