NovaTears® Eye Drops Observational Study NT-002

NCT ID: NCT02356341

Last Updated: 2016-03-09

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

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-12-31

Brief Summary

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This observational study is intended to collect outcome data from a cohort of 90 patients suffering from symptoms of dry eye disease due to meibomian gland dysfunction who are treated with the medical device NovaTears® eye drops for a duration of 6 to 8 weeks.

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 with dry eye disease due to meibomian gland dysfunction 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 dry eye disease not caused by meibomian gland dysfunction
* Patients taking lipid containing eye drops or requiring topical pharmacological treatment of dry eye disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novaliq GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novaliq GmbH

Role: STUDY_DIRECTOR

Novaliq GmbH

Locations

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Prof. Dr. Norbert Schrage

Cologne, , Germany

Site Status

University Eye Hospital of the HHU Duesseldorf

Düsseldorf, , Germany

Site Status

University Eye Hospital of the FAU Erlangen-Nuremberg

Erlangen, , Germany

Site Status

University Eye Hospital Heidelberg

Heidelberg, , Germany

Site Status

Dr. Thomas Kaercher

Heidelberg, , Germany

Site Status

JenVis Research Institute

Jena, , Germany

Site Status

Staedtisches Klinikum Karlsruhe

Karlsruhe, , Germany

Site Status

University Eye Hospital, LMU Munich

Munich, , Germany

Site Status

Countries

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Germany

References

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Steven P, Augustin AJ, Geerling G, Kaercher T, Kretz F, Kunert K, Menzel-Severing J, Schrage N, Schrems W, Krosser S, Beckert M, Messmer EM. Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease Due to Meibomian Gland Disease. J Ocul Pharmacol Ther. 2017 Nov;33(9):678-685. doi: 10.1089/jop.2017.0042. Epub 2017 Sep 18.

Reference Type DERIVED
PMID: 28922088 (View on PubMed)

Other Identifiers

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NT-002

Identifier Type: -

Identifier Source: org_study_id

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