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Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL. (DEXTENZA)

Primary Purpose

Cataract

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dextenza 0.4Mg Ophthalmic Insert
Sponsored by
Iworks Laser and Vision Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring PCIOL, CCI CE

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Subjects will be eligible for study participation if they:

  1. Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes with or without iStent/Hydrus/Goniotomy.
  2. Are willing and able to comply with clinic visits and study related procedures.
  3. Are willing and able to sign the informed consent form.
  4. Not pregnant.

Subjects are not eligible for study participation if they:

  1. Are currently being treated with corticosteroid implant (i.e. Ozurdex).
  2. Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye.
  3. Have a history of complete punctal occlusion in one or both punctum.
  4. Currently use topical ophthalmic steroid medications.
  5. Are unwilling or unable to comply with the study protocol.
  6. 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.
  7. Have active infectious systemic disease.
  8. Have active infectious ocular or extraocular disease.
  9. Have unobstructed nasolacrimal duct in the study eye(s) (dacrocystitis).
  10. Have known hypersensitivity to dexamethasone or are a known steroid responder.
  11. Have a history of ocular inflammation or macular edema.
  12. Are currently being treated with immunomodulating agents in the study eye(s).
  13. Are currently being treated with immunosuppressants an/or oral steroids.
  14. Are Pregnant or breast-feeding or wish to become pregnant during the length of study participation.

Sites / Locations

  • Iworks Laser & Vision Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Lower Punctum Insertion (Group 1)

Upper Punctum Insertion (Group 2)

Arm Description

DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use Group 1 (up to 40 eyes) will receive the insert in the lower punctum on the day of surgery in the OR.

DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use Group 2 (up to 40 eyes) will receive the insert in the upper punctum on the of surgery in the OR.

Outcomes

Primary Outcome Measures

Participants With Complete Absence of Ocular Pain at Day 8
Participant reported ocular pain on a scale of (0-10) with zero (0) equaling no pain and ten(10) equaling maximal pain on day 8.
Participants With Zero Cells on Day 14
Proportion of of participants with complete absence of anterior chamber cell at Day 14 as measured by Summed Ocular Inflammation Score (0-4).

Secondary Outcome Measures

Ease of Insertion
Rated as Easy, Moderate, Difficult
Attempts to Achieve Successful Insertion
Number of attempts to insert the dexamethasone insert in the upper or lower punctum.

Full Information

First Posted
May 6, 2022
Last Updated
July 31, 2023
Sponsor
Iworks Laser and Vision Center
Collaborators
Ocular Therapeutix, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05372315
Brief Title
Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL.
Acronym
DEXTENZA
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).
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iworks Laser and Vision Center
Collaborators
Ocular Therapeutix, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.
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) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
PCIOL, CCI CE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Model Description
Each subject's participation is expected to last for approximately 1 month and will be required to complete six scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 8, Day 14 and Day 30.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lower Punctum Insertion (Group 1)
Arm Type
Other
Arm Description
DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use Group 1 (up to 40 eyes) will receive the insert in the lower punctum on the day of surgery in the OR.
Arm Title
Upper Punctum Insertion (Group 2)
Arm Type
Other
Arm Description
DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use Group 2 (up to 40 eyes) will receive the insert in the upper punctum on the of surgery in the OR.
Intervention Type
Drug
Intervention Name(s)
Dextenza 0.4Mg Ophthalmic Insert
Intervention Description
(dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery.
Primary Outcome Measure Information:
Title
Participants With Complete Absence of Ocular Pain at Day 8
Description
Participant reported ocular pain on a scale of (0-10) with zero (0) equaling no pain and ten(10) equaling maximal pain on day 8.
Time Frame
at Day 8
Title
Participants With Zero Cells on Day 14
Description
Proportion of of participants with complete absence of anterior chamber cell at Day 14 as measured by Summed Ocular Inflammation Score (0-4).
Time Frame
at Day 14
Secondary Outcome Measure Information:
Title
Ease of Insertion
Description
Rated as Easy, Moderate, Difficult
Time Frame
Day 0
Title
Attempts to Achieve Successful Insertion
Description
Number of attempts to insert the dexamethasone insert in the upper or lower punctum.
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects will be eligible for study participation if they: Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes with or without iStent/Hydrus/Goniotomy. Are willing and able to comply with clinic visits and study related procedures. Are willing and able to sign the informed consent form. Not pregnant. Exclusion Criteria: Subjects are not eligible for study participation if they: 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. Have active infectious systemic disease. Have active infectious ocular or extraocular disease. Have unobstructed nasolacrimal duct in the study eye(s) (dacrocystitis). 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 an/or oral steroids. Are Pregnant or breast-feeding or wish to become pregnant during the length of study participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick L Spencer, DO
Organizational Affiliation
Iworks Laser & Vision Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iworks Laser & Vision Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45405
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32821083
Citation
Greenwood MD, Gorham RA, Boever KR. A Randomized Fellow-Eye Clinical Trial to Evaluate Patient Preference for Dexamethasone Intracanalicular Insert or Topical Prednisolone Acetate for Control of Postoperative Symptoms Following Bilateral Femtosecond Laser in Site Keratomileusis (LASIK). Clin Ophthalmol. 2020 Aug 6;14:2223-2228. doi: 10.2147/OPTH.S265311. eCollection 2020.
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Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL.

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