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Completed

NCT Number: NCT03488017

Ocular Coil Drug Delivery Comfort Trial

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Hospital Maastricht

Maastricht, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ocular Coil

Device

Non-invasive ocular device

Primary outcomes

  1. Change from baseline in terms of ocular irritation

    Time frame: 28 days

    Ocular irritation is assessed by slit lamp microscopy through evaluation of the ocular redness, inflammatory cells and flare.

Secondary outcomes

  1. Total time of Ocular Coil retention

    Time frame: 28 days

    The total number of days that the Ocular Coil is worn by the participant (from placement until removal) is recorded.

  2. Percentage of Participants in Each Response Category of Subject Comfort

    Time frame: 28 days

    Subject comfort is assessed via a custom-made questionnaire. This questionnaire includes several questions related to eye comfort (itchy feeling, foreign feeling, etc.) and uses a 5-point scale (from agree to do not agree) and a 4-point scale (from always to never). The percentage of participants in each response category is recorded.

  3. Incidence of ocular adverse events

    Time frame: 28 days

    Incidence of ocular adverse events related to the Ocular Coil or the associated procedures (placement and removal) is evaluated.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Evaluation of the Safety and Tolerability of an Ocular Coil

Acronym: OCDC

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 4, 2018
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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