Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

NCT05626478 | Completed Phase 4 FDA Drug

• 1 other identifier: AVC-003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

Conditions

Corneal Defect; Anterior Chamber Inflammation; Ocular Pain; Corneal Staining; Visual Outcome; CME - Cystoid Macular Edema; Corneal Edema

Outcome Measures

Primary Outcomes (2)

• Mean change in anterior chamber inflammation (Cell and Flare) scores

  Measured by SUN (Standardization on Uveitis Nomenclature) grading scale: absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of: 0-1. 0-4 score scale, higher scores mean a worse outcome. 0-1 Absent, 1-2 Mild, 2-3 Moderate, 4 Severe.

  Assessed on Days 1,7,30,90

• Mean change in pain score

  Measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worst pain possible, higher scores mean a worse outcome. 0-10 Absent, 11-30 Mild, 31-70 Moderate, 71-100 Severe.

  Assessed on Day 1,7, 30 and 90

Secondary Outcomes (3)

• Visual outcome (Best Corrected Visual Acuity)

  Assessed on Day 1,7, 30 and 90

• Absence of CME (Cystoid Macular Edema)

  Assessed on Day 90

• Mean change in corneal staining

  Assessed on Day 7, 30 and 90

Other Outcomes (3)

• Safety endpoint: corneal or retinal edema

  Assessed throughout 90-day study period

• Safety endpoint: Signs of Rebound Iritis

  Assessed throughout 90-day study period

• Safety endpoint: Change in IOP (IntraOcular Pressure) initiating rescue medications

  Assessed throughout 90-day study period

Study Arms (2)

Arm 1 - Cataract surgery gtt regimen per SOC

ACTIVE COMPARATOR

Following cataract surgery (without Dextenza 0.4mg insert) patients will receive: Prednisolone Acetate 1% QID X 2 Weeks, then BID x 2 weeks and stop / Prolensa 0.07% QD X 4 Weeks and stop.

Drug: Prednisolone Acetate 1% Oph Susp; Drug: Prolensa 0.07% Ophthalmic Solution

Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimen

EXPERIMENTAL

Following cataract surgery with DEXTENZA 0.4mg insert, patients will receive: Prolensa 0.07% QD X 4 Weeks and stop

Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Prolensa 0.07% Ophthalmic Solution

Interventions

Prednisolone Acetate 1% Oph Susp DRUG

Prednisolone Acetate 1% is a corticosteroid (to decrease inflammation) and being used as a topical drop after cataract surgery per Standard Of Care.

Arm 1 - Cataract surgery gtt regimen per SOC

Prolensa 0.07% Ophthalmic Solution DRUG

Prolensa 0.07% is a NSAID (to decrease inflammation, swelling and pain) and is being used as a topical drop after cataract surgery per Standard Of Care.

Arm 1 - Cataract surgery gtt regimen per SOC; Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimen

Dextenza 0.4Mg Ophthalmic Insert DRUG

DEXTENZA 0.4Mg Ophthalmic Insert is a corticosteroid (to decrease inflammation) intracanalicular insert placed in the punctum, a natural opening in the eye lid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives.

Also known as: Dexamethasone 0.4mg

Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with clinically significant cataract and are planning to undergo non-complicated Clear Cornea Incision Cataract Extraction with Posterior Capsule IntraOcular Lens 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

You may not qualify if:

• Under the age of 18 at the time of signing the Informed Consent Form
• Pregnant or planning to become pregnant during the trial period
• Have visual acuity potential of less than 20/30 as recorded by a Retinal Acuity Meter or Potential Acuity Meter glare testing
• Have active infectious systemic disease
• Have active infectious ocular or extraocular disease
• Have punctal plug in the study eye
• Have obstructed nasolacrimal duct in the study eye(s) (dacryocystitus)
• Have known hypersensitivity to dexamethasone or are a known steroid responder
• Have a history of ocular inflammation or macular edema
• Has history of Laser Vision Correction (LASIK, PhotoRefractive Keratectomy) in the operated eye
• Are currently being treated with immunomodulating agents in the study eye
• 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

Sponsors & Collaborators

• Nicole Fram M.D.: lead

Study Sites (1)

Advanced Vision Care

Los Angeles, California, 90067, United States

Location

Related Publications (20)

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• Patel SB, Reddy NK, He YG. TOXIC POSTERIOR SEGMENT SYNDROME AFTER DROPLESS CATARACT SURGERY WITH COMPOUNDED TRIAMCINOLONE-MOXIFLOXACIN. Retina. 2020 Mar;40(3):446-455. doi: 10.1097/IAE.0000000000002450.

  PMID: 30689622 BACKGROUND

• Freire FS, Lang R, Abalem MF, Johnson MW. RETINAL DEPOSITS OF TRIAMCINOLONE-MOXIFLOXACIN AFTER DROPLESS CATARACT SURGERY. Retin Cases Brief Rep. 2023 Sep 1;17(5):577-580. doi: 10.1097/ICB.0000000000001243.

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• Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057.

  PMID: 16196117 BACKGROUND

• Ibach MJ, Zimprich L, Wallin DD, Olevson C, Puls-Boever K, Thompson V. In Clinic Optometrist Insertion of Dextenza (Dexamethasone Ophthalmic Insert 0.4mg) Prior to Cataract Surgery: The PREPARE Study. Clin Ophthalmol. 2022 Aug 13;16:2609-2615. doi: 10.2147/OPTH.S374405. eCollection 2022.

  PMID: 35992569 BACKGROUND

• Ibach MJ, Shafer BM, Wallin DD, Puls-Boever KR, Thompson VM, Berdahl JP. The Effectiveness and Safety of Dextenza 0.4 mg for the Treatment of Postoperative Inflammation and Pain in Patients After Photorefractive Keratectomy: The RESTORE Trial. J Refract Surg. 2021 Sep;37(9):590-594. doi: 10.3928/1081597X-20210610-05. Epub 2021 Sep 1.

  PMID: 34506241 BACKGROUND

• Alsetri H, Fram N, Shiler O. Evaluating a Sustained-Release Dexamethasone Insert as Adjunctive Therapy for Inflammation and Pain Post-Corneal Transplantation. Clin Ophthalmol. 2024 Jul 16;18:2083-2091. doi: 10.2147/OPTH.S466118. eCollection 2024.

  PMID: 39051020 BACKGROUND

• Fram N, Alsetri H, Shiler O, Paterno PJ, Cabang J. Retrospective Study of a Sustained-Release Intracanalicular Dexamethasone Insert for Treatment of Ocular Inflammation After Cataract and Corneal Surgery. Clin Ophthalmol. 2022 Dec 10;16:4065-4074. doi: 10.2147/OPTH.S386702. eCollection 2022.

  PMID: 36532822 BACKGROUND

• Shapiro JN, Armenti ST, Levine H, Hood CT, Mian SI. Dexamethasone Intracanalicular Insert versus Standard Topical Steroids for the Prophylaxis of Inflammation after Cataract Surgery. Am J Ophthalmol. 2024 Dec;268:174-180. doi: 10.1016/j.ajo.2024.07.030. Epub 2024 Jul 31.

  PMID: 39089352 BACKGROUND

• Tyson SL, Bafna S, Gira JP, Goldberg DF, Jones JJ, Jones MP, Kim JK, Martel JM, Nordlund ML, Piovanetti-Perez IK, Singh IP, Metzinger JL, Mulani D, Sane S, Talamo JH, Goldstein MH; Dextenza Study Group. Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2019 Feb;45(2):204-212. doi: 10.1016/j.jcrs.2018.09.023. Epub 2018 Oct 24.

  PMID: 30367938 BACKGROUND

• Walters T, Endl M, Elmer TR, Levenson J, Majmudar P, Masket S. Sustained-release dexamethasone for the treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2015 Oct;41(10):2049-59. doi: 10.1016/j.jcrs.2015.11.005.

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Related Links

• Dextenza \[package insert\]. Bedford, MA: Ocular Therapeutix, Inc; 2019

MeSH Terms

Conditions

Corneal Edema; Eye Pain; Macular Edema

Interventions

Calcium Dobesilate; Dexamethasone; prednisolone acetate; bromfenac; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Eye Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Macular Degeneration; Retinal Degeneration; Retinal Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Nicole R Fram, M.D.

  Advanced Vision Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: CEO

Model Details: In patient who undergo cataract surgery, subjects will be randomized to 2 arms and be followed for a period of 3 months. Arm 1- control group, 25 subjects will receive Prednisolone Acetate 1% QID x 2 weeks then BID x 2 weeks. Arm 2 - study group, 25 subjects will receive Dextenza 0.4mg insert

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 23, 2022
• Study Start: June 1, 2023
• Primary Completion: February 5, 2025
• Study Completion: February 5, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)