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

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).

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Drug: Dextenza 0.4Mg Ophthalmic Insert

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Dayton, Ohio, United States, 45405
      • Iworks Laser & Vision Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lower Punctum Insertion (Group 1); 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.	Drug: Dextenza 0.4Mg Ophthalmic Insert; (dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery.
Other: Upper Punctum Insertion (Group 2); 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.	Drug: Dextenza 0.4Mg Ophthalmic Insert; (dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 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).	at Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of Insertion	Rated as Easy, Moderate, Difficult	Day 0
Attempts to Achieve Successful Insertion	Number of attempts to insert the dexamethasone insert in the upper or lower punctum.	Day 0

Collaborators and Investigators

• Sponsor: Iworks Laser and Vision Center
• Collaborators: Ocular Therapeutix, Inc.
• Investigators: Principal Investigator: Patrick L Spencer, DO, Iworks Laser & Vision Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: PCIOL; CCI CE
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: SPENCER-2022-401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No