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

Sponsor
Ocular Therapeutix, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04945824
Collaborator
(none)
45
1
1
6
7.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexamethasone Ophthalmic
  • Device: Dilator
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Novel Intracanalicular Insertion Device

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

Outcome Measures

Primary Outcome Measures

  1. Ease of insertion as assessed by Post-Insertion Investigator Questionnaire [Assessed at Visit 1 (Day 1)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ocular Therapeutix, Inc. Sioux Falls South Dakota United States 57108

Sponsors and Collaborators

  • Ocular Therapeutix, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier:
NCT04945824
Other Study ID Numbers:
  • OTX-DPI-2020-401
First Posted:
Jun 30, 2021
Last Update Posted:
Jun 30, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 30, 2021