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

Early Phase 1TerminatedNCT04945824

Ocular Therapeutix, Inc.2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Dexamethasone OphthalmicDRUG

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.

DilatorDEVICE

Intracanalicular Dilator Device

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ocular Therapeutix, Inc.

Sioux Falls, South Dakota, United States

Outcomes

Primary Outcomes

Ease of insertion as assessed by Post-Insertion Investigator Questionnaire

Time frame: Assessed at Visit 1 (Day 1)

Data from ClinicalTrials.gov

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