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

Phase 4

• Conditions: Post-Surgical Ocular Pain; Post-Surgical Ocular Inflammation
• Interventions: Drug: Dextenza 0.4Mg Ophthalmic Insert

• Registration Number: NCT04592081
• Lead Sponsor: Kerry Assil, MD

Brief Summary

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

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 Timeline

• Study Start: 2020-08-01
• Status Verified: 2020-10
• Study First Submitted: 2020-10-02
• Study First Submitted QC: 2020-10-16
• Last Update Submitted: 2020-10-16
• Study First Posted: 2020-10-19
• Last Update Posted: 2020-10-19
• Primary Completion: 2021-02-01
• Study Completion: 2021-03-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEXTENZA placed within the lower canaliculus	Dextenza 0.4Mg Ophthalmic Insert	Dextenza placed within the lower canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation.
DEXTENZA placed within the upper canaliculus	Dextenza 0.4Mg Ophthalmic Insert	Dextenza placed within the upper canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation.

Primary Outcome Measures

Name	Time	Method
Post-operative inflammation scores	Assessed on Days 1, 7, 30 for change	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.
Post-op pain scores	Assessed on Days 1, 7, 30 for change	As measured on a scale from 0-10

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Assil Eye Institute; 🇺🇸 Beverly Hills, California, United States