Ocular Coil Drug Delivery Comfort Trial (OCDC)

August 7, 2019 updated by: Maastricht University Medical Center

Evaluation of the Safety and Tolerability of an Ocular Coil

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Academic Hospital Maastricht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo Ocular Coil (left eye)
Left eye
Device: Ocular Coil
Non-invasive ocular device
Experimental: Placebo Ocular Coil (right eye)
Right eye
Device: Ocular Coil
Non-invasive ocular device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 days
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.
28 days
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.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

August 2, 2019

Study Completion (Actual)

August 2, 2019

Study Registration Dates

First Submitted

March 19, 2018

First Submitted That Met QC Criteria

April 3, 2018

First Posted (Actual)

April 4, 2018

Study Record Updates

Last Update Posted (Actual)

August 8, 2019

Last Update Submitted That Met QC Criteria

August 7, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 161042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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