Ocular Coil Drug Delivery Comfort Trial

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Device: Ocular Coil

• Registration Number: NCT03488017
• Lead Sponsor: Maastricht University Medical Center

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.

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 Timeline

• Study First Submitted: 2018-03-19
• Study First Submitted QC: 2018-04-03
• Study First Posted: 2018-04-04
• Study Start: 2018-06-01
• Status Verified: 2019-08
• Primary Completion: 2019-08-02
• Study Completion: 2019-08-02
• Last Update Submitted: 2019-08-07
• Last Update Posted: 2019-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Ocular Coil (left eye)	Ocular Coil	Left eye
Placebo Ocular Coil (right eye)	Ocular Coil	Right eye

Primary Outcome Measures

Name	Time	Method
Change from baseline in terms of ocular irritation	28 days	Ocular irritation is assessed by slit lamp microscopy through evaluation of the ocular redness, inflammatory cells and flare.

Secondary Outcome Measures

Name	Time	Method
Total time of Ocular Coil retention	28 days	The total number of days that the Ocular Coil is worn by the participant (from placement until removal) is recorded.
Percentage of Participants in Each Response Category of Subject Comfort	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.
Incidence of ocular adverse events	28 days	Incidence of ocular adverse events related to the Ocular Coil or the associated procedures (placement and removal) is evaluated.

Trial Locations

Locations (1)

Academic Hospital Maastricht; 🇳🇱 Maastricht, Netherlands