The SITE Study - Dexamethasone Ophthalmic Insert In OR on Day of Surgery Versus In-office Post-Op Day 1
NCT ID: NCT05143281
Last Updated: 2023-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
23 participants
INTERVENTIONAL
2021-12-13
2023-02-01
Brief Summary
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Detailed Description
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There will be approximately 50 eyes with two groups:
Group 1 (up to 10 eyes) will receive the insert in the lower punctum on the day of surgery in the OR.
Group 2 (up to 40 eyes) will receive the insert in the lower punctum on the day after surgery in the HOPD.
Each subject's participation is expected to last for approximately 1 month and will be required to complete five scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 7 and Day 30.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dexamethasone Ophthalmic Insert Day of Surgery
Day of surgery, in OR placement
Dexamethasone 0.4 MG [Dextenza]
Ophthalmic Intracanalicular Insert
Dexamethasone Ophthalmic Insert Day 1 Post Op
Day 1 Post-Op, In-office (HOPD)
Dexamethasone 0.4 MG [Dextenza]
Ophthalmic Intracanalicular Insert
Interventions
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Dexamethasone 0.4 MG [Dextenza]
Ophthalmic Intracanalicular Insert
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Are an adult subject aged 65 years or older Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes 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 active infectious systemic disease Have active infectious ocular or extraocular disease Have unobstructed nasolacrimal duct in the study eye(s) Have known hypersensitivity to dexamethasone or are a known steroid responder Have a history of ocular inflammation or macular edema Are currently being treated with immunomodulating agents in the study eye(s) Are currently being treated with immunosuppressants and/or oral steroids Are currently being treated with corticosteroid implant (i.e. Ozurdex) 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 disease/abnormality) or if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment
65 Years
ALL
No
Sponsors
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Ocular Therapeutix, Inc.
INDUSTRY
Grene Vision Group
OTHER
Responsible Party
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Principal Investigators
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Anita Campbell, MD
Role: PRINCIPAL_INVESTIGATOR
Grene Vision Group
Locations
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Grene Vision Group
Wichita, Kansas, United States
Grene Vision Group
Wichita, Kansas, United States
Countries
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Other Identifiers
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SITE-2021-4001
Identifier Type: -
Identifier Source: org_study_id
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