Ocular Coil Drug Delivery Comfort Trial

NCT ID: NCT03488017

Last Updated: 2019-08-08

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

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-08-02

Brief Summary

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The Ocular Coil is intended to provide drug delivery to the ocular surface. This study will evaluate the safety and tolerability of the placebo Ocular Coil in healthy subjects.

Detailed Description

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This study is designed to evaluate the safety and comfort of a placebo Ocular Coil for 28 days in 40 healthy subjects.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Placebo Ocular Coil (left eye)

Left eye

Group Type EXPERIMENTAL

Ocular Coil

Intervention Type DEVICE

Non-invasive ocular device

Placebo Ocular Coil (right eye)

Right eye

Group Type EXPERIMENTAL

Ocular Coil

Intervention Type DEVICE

Non-invasive ocular device

Interventions

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Ocular Coil

Non-invasive ocular device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 75 years old
* Informed and having given informed consent
* Willing and able to comply with scheduled visits and other study procedures

Exclusion Criteria

* Subjects with a history of eye disease that can make them vulnerable for irritation by the coil.
* Subjects wearing contact lenses (unless they are willing to replace them for glasses for the duration of the study).
* Subjects using eye drops (during the study).
* Subjects with an Oriental/Asian lid crease, because of their narrow fornix.
* Subjects who do not speak and/or write Dutch properly.
* Subjects with a history of serious adverse reaction or hypersensitivity to components of the ocular coil. or to ophthalmic anaesthetics
* Women who are pregnant or nursing their child, or have the intention to become pregnant during the course of the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Academic Hospital Maastricht

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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161042

Identifier Type: -

Identifier Source: org_study_id

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