Ocular Coil Drug Delivery Comfort Trial (OCDC)

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Healthy Volunteers

Treatments

Device: Ocular Coil

Study type

Interventional

Funder types

Other

Identifiers

NCT03488017

161042

Details and patient eligibility

About

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.

Full description

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

Enrollment

42 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.