NCT03488017

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 4, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2019

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

1.2 years

First QC Date

March 19, 2018

Last Update Submit

August 7, 2019

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in terms of ocular irritation

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

    28 days

Secondary Outcomes (3)

  • Total time of Ocular Coil retention

    28 days

  • Percentage of Participants in Each Response Category of Subject Comfort

    28 days

  • Incidence of ocular adverse events

    28 days

Study Arms (2)

Placebo Ocular Coil (left eye)

EXPERIMENTAL

Left eye

Device: Ocular Coil

Placebo Ocular Coil (right eye)

EXPERIMENTAL

Right eye

Device: Ocular Coil

Interventions

Ocular CoilDEVICE

Non-invasive ocular device

Placebo Ocular Coil (left eye)Placebo Ocular Coil (right eye)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Hospital Maastricht

Maastricht, Netherlands

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2018

First Posted

April 4, 2018

Study Start

June 1, 2018

Primary Completion

August 2, 2019

Study Completion

August 2, 2019

Last Updated

August 8, 2019

Record last verified: 2019-08

Locations

NL(1)