Dextenza Within Upper Lid Canaliculus Compared With Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With PCIOL.

A Randomized Controlled Clinical Trial aSsessing the Efficacy of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert When Placed Within the Upper Eye Lid Canaliculus in Comparison to the Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With Posterior Chamber Intraocular Lens Implant (CE/PCIOL).

Assessing DEXTENZA efficacy when placed within the upper eyelid canaliculus as opposed to the lower eyelid canaliculus.

Study Overview

• Status: Unknown
• Conditions: Post-Surgical Ocular Pain; Post-Surgical Ocular Inflammation
• Intervention / Treatment: Drug: Dextenza 0.4Mg Ophthalmic Insert

Detailed Description

Randomized controlled clinical trial assessing the efficacy of DEXTENZA, sustained release dexamethasone 0.4 mg insert when placed within the upper eye lid canaliculus in comparison to the lower lid canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lens implant (CE/PCIOL).

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kellie Burch; Phone Number: 310-651-2392; Email: kburch@assileye.com

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90210
      • Recruiting
      • Assil Eye Institute
      • Sub-Investigator: Lindsay Harris
      • Principal Investigator: Kerry Assil, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Been diagnosed with clinically significant cataract and CE/PCIOL has been planned
• Bilateral cataract surgery with IOL has been planned
• Willing and able to comply with clinic visits and study related procedures
• Willing and able to sign the informed consent form

Exclusion Criteria:

• Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
• Active infectious systemic disease
• Active infectious ocular or extraocular disease
• Obstructed nasolacrimal duct in the study eye(s)
• Hypersensitivity to dexamethasone
• Patients being treated with immunomodulating agents in the study eye(s)
• History of prior ocular surgery, excluding Lasik or PRK
• History of ocular inflammation or macular edema
• Use of any systemic NSAIDs greater than 375 mg per day
• Patients being treated with immunosuppressants and/or oral steroids
• Patients with a corticosteroid implant (i.e. Ozurdex)
• Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DEXTENZA placed within the upper canaliculus; Dextenza placed within the upper canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation.	Drug: Dextenza 0.4Mg Ophthalmic Insert; Dextenza 0.4Mg Ophthalmic Insert
Active Comparator: DEXTENZA placed within the lower canaliculus; Dextenza placed within the lower canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation.	Drug: Dextenza 0.4Mg Ophthalmic Insert; Dextenza 0.4Mg Ophthalmic Insert

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative inflammation scores	As measured on a scale of 0-4: absence of cell to be defined as a grade of 0-0.5, absence of flare to be defined as a grade of 0-1.	Assessed on Days 1, 7, 30 for change
Post-op pain scores	As measured on a scale from 0-10	Assessed on Days 1, 7, 30 for change

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of Insertion (successful implantation)	As measured by Physician Ease of Use Questionnaire	Assessed on Day 0 (Day of Insertion)
Intraocular Pressure	As measured by Goldmann Applanation	Assessed on Days 1, 7, 30, 90 for change
Visual Outcome	As measured by BCVA	Assessed at all time points;comparison of Day 30 vs Day 90
Absence of CME	As measured by OCT	Assessed on Day -30 to -1 and Day 90 for change
Need of additional steroids	As measured by rescue medication added	Assessed on Days 1, 7, 30, 90 for change
Absence of rebound iritis	As measured by presence of cells	Assessed on Days 1, 7, 30, 90 for change
Patient reported outcomes	As measured by patient questionnaire	Assessed on Day 90

Collaborators and Investigators

• Sponsor: Kerry Assil, MD
• Investigators: Principal Investigator: Kerry Assil, MD, Assil Eye Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): March 11, 2021

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Inflammation; Eye Diseases; Cataract; Dexamethasone; Anti-Inflammatory Agents; Capsule Opacification; Lens Diseases
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Lens Diseases; Inflammation; 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: The Assil Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No