A Human Factors Study to Evaluate a Novel Intracanalicular Insertion Device in Healthy Subjects
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 |
---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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
- Ease of insertion as assessed by Post-Insertion Investigator Questionnaire [Assessed at Visit 1 (Day 1)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Are a healthy adult subject aged 18 years or older with no known significant health problems
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Are willing to refrain from wearing contact lens for the duration of the study
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Are willing and able to comply with clinic visits and study related procedures
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Are willing and able to sign the informed consent form
Exclusion Criteria:
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Have known significant health problems
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Are women of reproductive potential
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Are breastfeeding
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Are a known steroid responder
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Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye
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Have a history of complete punctal occlusion in one or both punctum
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Currently use topical ophthalmic steroid medications
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Are unwilling or unable to comply with the study protocol
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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.- OTX-DPI-2020-401