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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04945824
• Other study ID #: OTX-DPI-2020-401
• Status: Terminated
• Phase: Early Phase 1
• Start date: June 1, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: February 2023
• Source: Ocular Therapeutix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	Ocular Therapeutix, Inc.	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ease of insertion as assessed by Post-Insertion Investigator Questionnaire		Assessed at Visit 1 (Day 1)