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The SITE Study - Dexamethasone Ophthalmic Insert In OR on Day of Surgery Versus In-office Post-Op Day 1

NCT ID: NCT05100186

Last Updated: 2021-10-29

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-02-28

Brief Summary

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To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) compared to insertion 1-day post-op.

Detailed Description

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This is a randomized, controlled study to evaluate the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) compared to insertion 1-day post-op.

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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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexamethasone Ophthalmic Insert

Day of surgery, in OR placement versus Day 1 Post-Op, In-office (HOPD)

Group Type EXPERIMENTAL

Dexamethasone 0.4 MG [Dextenza]

Intervention Type DRUG

Dextenza

Interventions

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Dexamethasone 0.4 MG [Dextenza]

Dextenza

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects will be eligible for study participation if they:

1. Are an adult subject aged 65 years or older
2. Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes
3. Are willing and able to comply with clinic visits and study related procedures
4. Are willing and able to sign the informed consent form

Exclusion Criteria

* Subjects are not eligible for study participation if they:

1. Have active infectious systemic disease
2. Have active infectious ocular or extraocular disease
3. Have unobstructed nasolacrimal duct in the study eye(s)
4. Have known hypersensitivity to dexamethasone or are a known steroid responder
5. Have a history of ocular inflammation or macular edema
6. Are currently being treated with immunomodulating agents in the study eye(s)
7. Are currently being treated with immunosuppressants and/or oral steroids
8. Are currently being treated with corticosteroid implant (i.e. Ozurdex)
9. Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye
10. Have a history of complete punctal occlusion in one or both punctum
11. Currently use topical ophthalmic steroid medications
12. Are unwilling or unable to comply with the study protocol
13. 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Joseph Kavanagh, MD

OTHER

Sponsor Role lead

Responsible Party

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Joseph Kavanagh, MD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Joseph T Kavanagh, MD

Role: CONTACT

Phone: 210-387-0363

Email: [email protected]

Anita Holland

Role: CONTACT

Phone: 210-387-0363

Email: [email protected]

Other Identifiers

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SITE-2021-4002

Identifier Type: -

Identifier Source: org_study_id