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

Phase 4

• Conditions: Cataract
• Interventions: Drug: Dexamethasone 0.4 MG [Dextenza]

• Registration Number: NCT05100186
• Lead Sponsor: Joseph Kavanagh, MD

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-27
• Last Update Submitted: 2021-10-27
• Study First Posted: 2021-10-29
• Last Update Posted: 2021-10-29
• Study Start: 2021-11-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dexamethasone Ophthalmic Insert	Dexamethasone 0.4 MG [Dextenza]	Day of surgery, in OR placement versus Day 1 Post-Op, In-office (HOPD)

Primary Outcome Measures

Name	Time	Method
Ocular Pain	Assessed on Day 7	As measured by ocular pain assessment numerical grading scale (0-10)
Anterior Chamber Cells	Assessed on Day 7	As measured by summed ocular inflammation score (0-4)

Secondary Outcome Measures

Name	Time	Method
Percentage with complete absence of cell	Assessed on Day -1, Day 1, Day 7, Day 30	As measured by summed ocular inflammation score (0-4)
Physician ease of insertion and visualization	Assessed on Day 1	As measured by physician questionnaire
Mean change in BCVA	Assessed on Day -1, Day 7, Day 30	As measured by snellen VA
Percentage with complete absence of pain	Assessed on Day -1, Day 1, Day 7, Day 30	As measured by ocular pain assessment numerical grading scale (0-10)