Ocular Coil Drug Delivery Comfort Trial

Healthy Volunteers Clinical Trial

— OCDC  

Official title:

Evaluation of the Safety and Tolerability of an Ocular Coil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03488017
• Other study ID #: 161042
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: August 2, 2019

Study information

• Verified date: August 2019
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 2, 2019
• Est. primary completion date: August 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• Ocular Coil
Non-invasive ocular device

Locations

Country	Name	City	State
Netherlands	Academic Hospital Maastricht	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

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