Healthy
Conditions
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.
Interventions
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.
DEVICEDilator
Intracanalicular Dilator Device
Sponsors
Ocular Therapeutix, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ease of insertion as assessed by Post-Insertion Investigator Questionnaire | Assessed at Visit 1 (Day 1) |
Countries
United States
Outcome results
None listed