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

NCT04945824 | Terminated Early Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: OTX-DPI-2020-401
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Ease of insertion as assessed by Post-Insertion Investigator Questionnaire

  Assessed at Visit 1 (Day 1)

Study Arms (1)

Novel Intracanalicular Insertion Device

EXPERIMENTAL

Drug: Dexamethasone Ophthalmic; Device: Dilator

Interventions

Dexamethasone Ophthalmic 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.

Novel Intracanalicular Insertion Device

Dilator DEVICE

Intracanalicular Dilator Device

Novel Intracanalicular Insertion Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ocular Therapeutix, Inc.: lead

Study Sites (1)

Ocular Therapeutix, Inc.

Sioux Falls, South Dakota, 57108, United States

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 30, 2021
• Study Start: June 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-02

Locations

US (1)