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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ocular Therapeutix, Inc.
• Treatments: Dexamethasone

Criteria

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