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

Cataract Clinical Trial

Official title:

A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment With an Intracanalicular Dexamethasone (0.4mg) Ophthalmic Insert in the Operating Room Following Cataract Surgery/Intraocular Lens Implant (IOL) Compared to Insertion 1-day Post-op - The SITE Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05100186
• Other study ID #: SITE-2021-4002
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 1, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: October 2021
• Source: Eye Associates of South Texas
• Contact: Joseph T Kavanagh, MD
• Phone: 210-387-0363
• Email: japlh4[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 28, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Dexamethasone 0.4 MG [Dextenza]
Dextenza

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Joseph Kavanagh, MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anterior Chamber Cells	As measured by summed ocular inflammation score (0-4)	Assessed on Day 7
Primary	Ocular Pain	As measured by ocular pain assessment numerical grading scale (0-10)	Assessed on Day 7
Secondary	Mean change in BCVA	As measured by snellen VA	Assessed on Day -1, Day 7, Day 30
Secondary	Percentage with complete absence of pain	As measured by ocular pain assessment numerical grading scale (0-10)	Assessed on Day -1, Day 1, Day 7, Day 30
Secondary	Percentage with complete absence of cell	As measured by summed ocular inflammation score (0-4)	Assessed on Day -1, Day 1, Day 7, Day 30
Secondary	Physician ease of insertion and visualization	As measured by physician questionnaire	Assessed on Day 1