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

NCT05143281 | Completed Phase 4 FDA Drug

• 1 other identifier: SITE-2021-4001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (2)

• Anterior Chamber Cells

  As measured by summed ocular inflammation score (0-4 with 4 meaning a worse outcome)

  Assessed on Day 7

• Ocular Pain

  As measured by ocular pain assessment numerical grading scale (0-10 with 10 meaning a worse outcome)

  Assessed on Day 7

Secondary Outcomes (4)

• Mean change in BCVA

  Assessed on Day -1, Day 7, Day 30

• Percentage with complete absence of pain

  Assessed on Day -1, Day 1, Day 7, Day 30

• Percentage with complete absence of cell

  Assessed on Day -1, Day 1, Day 7, Day 30

• Physician ease of insertion and visualization

  Assessed on Day 1

Study Arms (2)

Dexamethasone Ophthalmic Insert Day of Surgery

EXPERIMENTAL

Day of surgery, in OR placement

Drug: Dexamethasone 0.4 MG [Dextenza]

Dexamethasone Ophthalmic Insert Day 1 Post Op

EXPERIMENTAL

Day 1 Post-Op, In-office (HOPD)

Drug: Dexamethasone 0.4 MG [Dextenza]

Interventions

Dexamethasone 0.4 MG [Dextenza] DRUG

Ophthalmic Intracanalicular Insert

Also known as: Dextenza

Dexamethasone Ophthalmic Insert Day 1 Post Op; Dexamethasone Ophthalmic Insert Day of Surgery

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Subjects will be eligible for study participation if they:
• 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

You may not qualify if:

• Subjects are not eligible for study participation if they:
• 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

Sponsors & Collaborators

• Grene Vision Group: lead
• Ocular Therapeutix, Inc.: collaborator

Study Sites (2)

Grene Vision Group

Wichita, Kansas, 67208, United States

Location

Grene Vision Group

Wichita, Kansas, 67212, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Anita Campbell, MD

  Grene Vision Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 3, 2021
• Study Start: December 13, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)