NovaTears® Eye Drops Observational Study NT-003

Novaliq

Status: Completed

Conditions: Dry Eye Syndromes

Treatments: Device: NovaTears® Eye Drops

Study type: Observational

Funder types: Industry

Identifiers

NCT02356328

NT-003

Details and patient eligibility

About

This observational study is intended to collect outcome data from a cohort of 30 patients suffering from dry eye disease due to chronic ocular Graft-versus-Host Disease (GvHD) who are treated with the medical device NovaTears® eye drops for a duration of 11 to 13 weeks.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• According to NovaTears® instruction for use
• ≥ 18 years
• Patients after an allogeneic hematopoietic stem cell transplantation with dry eye disease due to chronic ocular Graft-versus-Host Disease
• Ability and willingness to provide written Informed Consent
• Ability and willingness to participate in all examinations
• Willingness and ability to return for follow up visit

Exclusion criteria

• Patients with known hypersensitivity to any of the components of NovaTears®
• Patients with contact lenses, pregnancies, or who are breast feeding
• Patients with dry eye disease caused by any other known underlying systemic disease
• Patients planning an ophthalmologic surgical procedure during the course of this PMCF study
• Patients using lipid-containing or tear-film stabilizing eye drops/sprays except cyclosporin formulations

Trial design

25 participants in 1 patient group

NovaTears®

Treatment:

Device: NovaTears® Eye Drops