NCT04945824

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

An Open-label, Multi-center, Bilateral, Human Factors Study to Evaluate the Utilization and Safety of a Novel Intracanalicular Insertion Device in Healthy Subjects

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Ocular Therapeutix, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	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.
DEVICE	Dilator	Intracanalicular Dilator Device

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2021-06-30
• Last updated: 2023-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study