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

NCT05100186 | Unknown Phase 4 FDA Drug

• 1 other identifier: SITE-2021-4002
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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)

  Assessed on Day 7

• Ocular Pain

  As measured by ocular pain assessment numerical grading scale (0-10)

  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 (1)

Dexamethasone Ophthalmic Insert

EXPERIMENTAL

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

Drug: Dexamethasone 0.4 MG [Dextenza]

Interventions

Dexamethasone 0.4 MG [Dextenza] DRUG

Dextenza

Dexamethasone Ophthalmic Insert

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

• Joseph Kavanagh, MD: lead

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

Central Study Contacts

Joseph T Kavanagh, MD

CONTACT

210-387-0363; japlh4@gmail.com

Anita Holland

CONTACT

210-387-0363; japlh4@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 29, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: February 28, 2022
• Last Updated: October 29, 2021

Record last verified: 2021-10