Ethics approval
RECRUITMENT, EYE
This prospective interventional randomized study included patients who were referred to Dry Eye clinic of the Department of Ophthalmology, University Hospital Duesseldorf, Germany, and healthy individuals without a history of DED who served as controls. All participants gave written informed consent for pseudonymized data analysis and anonymous publication during the recruitment process. The study and consent procedure were approved by the ethics committee of the University of Duesseldorf (no. 6057R), Germany, and adhered to the tenets of the Declaration of Helsinki. Our study is registered in the “German Clinical Trials Register” under the trial number: DRKS00028696. The results reported in this study are long-term data. Our reporting of results is completely transparent, and our clinical trial is registered in detail, so the quality remains high and retrospective registration did not influence the outcome of this study. The reason why we did not register our study in a registry is because we were under the impression that our local ethics committee´s approval was sufficient. The authors confirm that all ongoing and related trials for this drug/intervention are registered.