A Human Factors Study to Evaluate a Novel Intracanalicular Insertion Device in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-11-01

Brief Summary

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This is an open-label, multi-center, bilateral, human factors study designed to evaluate the utilization and safety of a novel intracanalicular insertion device in healthy subjects and to evaluate the concentration of DEXTENZA in tears. Each subject's participation is expected to last for approximately 1 month from the DEXTENZA insertion.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Novel Intracanalicular Insertion Device

Group Type EXPERIMENTAL

Dexamethasone Ophthalmic

Intervention Type DRUG

Insertion Device: A handheld mechanical device used by the clinician to dilate the punctum and deliver the DEXTENZA insert into the canaliculus; designed to be single-use and pre-loaded with a single DEXTENZA insert.

Dilator

Intervention Type DEVICE

Intracanalicular Dilator Device

Interventions

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Dexamethasone Ophthalmic

Insertion Device: A handheld mechanical device used by the clinician to dilate the punctum and deliver the DEXTENZA insert into the canaliculus; designed to be single-use and pre-loaded with a single DEXTENZA insert.

Intervention Type DRUG

Dilator

Intracanalicular Dilator Device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Are a healthy adult subject aged 18 years or older with no known significant health problems
* Are willing to refrain from wearing contact lens for the duration of the study
* Are willing and able to comply with clinic visits and study related procedures
* Are willing and able to sign the informed consent form

Exclusion Criteria

* Have known significant health problems
* Are women of reproductive potential
* Are breastfeeding
* Are a known steroid responder
* Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye
* Have a history of complete punctal occlusion in one or both punctum
* Currently use topical ophthalmic steroid medications
* Are unwilling or unable to comply with the study protocol
* Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes