NovaTears® Eye Drops Observational Study NT-003

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NovaTears®

NovaTears® Eye Drops

Intervention Type DEVICE

Topical eye drops for lubrication of the ocular surface

Interventions

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NovaTears® Eye Drops

Topical eye drops for lubrication of the ocular surface

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No