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

Early Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: Dexamethasone Ophthalmic; Device: Dilator

• Registration Number: NCT04945824
• Lead Sponsor: Ocular Therapeutix, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-30
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Novel Intracanalicular Insertion Device	Dexamethasone Ophthalmic	-
Novel Intracanalicular Insertion Device	Dilator	-

Primary Outcome Measures

Name	Time	Method
Ease of insertion as assessed by Post-Insertion Investigator Questionnaire	Assessed at Visit 1 (Day 1)

Trial Locations

Locations (1)

Ocular Therapeutix, Inc.; 🇺🇸 Sioux Falls, South Dakota, United States