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

Primary Purpose

Cataract

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Dexamethasone 0.4 MG [Dextenza]

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Grene Vision Group
Grene Vision Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Dexamethasone Ophthalmic Insert Day of Surgery

Dexamethasone Ophthalmic Insert Day 1 Post Op

Arm Description

Day of surgery, in OR placement

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

Outcomes

Primary Outcome Measures

Anterior Chamber Cells

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

Ocular Pain

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

Secondary Outcome Measures

Mean change in BCVA

As measured by snellen VA

Percentage with complete absence of pain

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

Percentage with complete absence of cell

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

Physician ease of insertion and visualization

As measured by physician questionnaire

Full Information

NCT ID

NCT05143281

First Posted

November 22, 2021

Last Updated

July 5, 2023

Sponsor

Grene Vision Group

Collaborators

Ocular Therapeutix, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05143281

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

December 13, 2021 (Actual)

Primary Completion Date

February 1, 2023 (Actual)

Study Completion Date

February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Grene Vision Group

Collaborators

Ocular Therapeutix, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexamethasone Ophthalmic Insert Day of Surgery

Arm Type

Experimental

Arm Description

Day of surgery, in OR placement

Arm Title

Dexamethasone Ophthalmic Insert Day 1 Post Op

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dexamethasone 0.4 MG [Dextenza]

Other Intervention Name(s)

Dextenza

Intervention Description

Ophthalmic Intracanalicular Insert

Primary Outcome Measure Information:

Title

Anterior Chamber Cells

Description

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

Time Frame

Assessed on Day 7

Title

Ocular Pain

Description

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

Time Frame

Assessed on Day 7

Secondary Outcome Measure Information:

Title

Mean change in BCVA

Description

As measured by snellen VA

Time Frame

Assessed on Day -1, Day 7, Day 30

Title

Percentage with complete absence of pain

Description

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

Time Frame

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

Title

Percentage with complete absence of cell

Description

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

Time Frame

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

Title

Physician ease of insertion and visualization

Description

As measured by physician questionnaire

Time Frame

Assessed on Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anita Campbell, MD

Organizational Affiliation

Grene Vision Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

Grene Vision Group

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67208

Country

United States

Facility Name

Grene Vision Group

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67212

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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