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

Ocular Therapeutix

Status and phase

Terminated

Early Phase 1

Conditions

Healthy

Treatments

Device: Dilator

Drug: Dexamethasone Ophthalmic

Study type

Interventional

Funder types

Industry

Identifiers

NCT04945824

OTX-DPI-2020-401

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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