NovaTears® Eye Drops Observational Study

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

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-05-31

Brief Summary

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This observational pilot-study is intended to collect outcome data from a cohort of 30 patients suffering from hyper-evaporative dry eye disease who are treated with the medical device NovaTears® eye drops for a duration of 5 to 7 weeks.

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Detailed Description

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Conditions

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Dry Eye Disease

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 with mild to moderate disease and hyper-evaporative dry eye disease applying eye lid hygiene for at least 14 days
* 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 hypersensitivity to any of the components of NovaTears®
* Patients with contact lenses, pregnancies, or who are breast feeding
* Patients with non evaporate dry eye disease
* Patients taking lipid containing eye drops or requiring pharmacologic treatment of dry eye disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No