Dry Eye Syndromes
Conditions
Brief summary
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.
Interventions
DEVICENovaTears® Eye Drops
Topical eye drops for lubrication of the ocular surface
Sponsors
Novaliq GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective symptom severity | 11-13 weeks | Change in subjective symptom severity score compared to Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear-Film Break-up Time | 11 to 13 weeks | Change in Tear Film Break-up Time (measured in seconds) compared to Baseline |
Countries
Germany
Outcome results
None listed