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

Phase 4

Active, not recruiting

• Conditions: Anterior Chamber Inflammation; Ocular Pain; Visual Outcome; Corneal Edema; Corneal Defect; Corneal Staining; CME - Cystoid Macular Edema
• Interventions: Drug: Prednisolone Acetate 1% Oph Susp; Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Prolensa 0.07% Ophthalmic Solution

• Registration Number: NCT05626478
• Lead Sponsor: Nicole Fram M.D.

Brief Summary

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

Detailed Description

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt Treating Pain, and inflamMation Following Cataract Surgery Compared to Topical Prednisolone Acetate 1%.

Study Timeline

• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-11-15
• Study First Posted: 2022-11-23
• Study Start: 2023-06-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Currently using 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) if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimen	Prolensa 0.07% Ophthalmic Solution	Following cataract surgery with DEXTENZA 0.4mg insert, patients will receive: Prolensa 0.07% QD X 4 Weeks and stop
Arm 1 - Cataract surgery gtt regimen per SOC	Prednisolone Acetate 1% Oph Susp	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.
Arm 1 - Cataract surgery gtt regimen per SOC	Prolensa 0.07% Ophthalmic Solution	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.
Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimen	Dextenza 0.4Mg Ophthalmic Insert	Following cataract surgery with DEXTENZA 0.4mg insert, patients will receive: Prolensa 0.07% QD X 4 Weeks and stop

Primary Outcome Measures

Name	Time	Method
Mean change in anterior chamber inflammation (Cell and Flare) scores	Assessed on Days 1,7,30,90	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.
Mean change in pain score	Assessed on Day 1,7, 30 and 90	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.

Secondary Outcome Measures

Name	Time	Method
Visual outcome (Best Corrected Visual Acuity)	Assessed on Day 1,7, 30 and 90	Measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart. 0-70 letter read score, higher scores mean a better outcome.
Absence of CME (Cystoid Macular Edema)	Assessed on Day 90	Macular thickness measured by OCT (Optical Coherence Tomography) and compared to the preop measurements, higher scores (\>over 50 microns) mean a worse outcome.
Mean change in corneal staining	Assessed on Day 7, 30 and 90	measured by the National Eye Institute 0-4 score scale, higher scores mean a worse outcome. 0-1 Mild, 2-3 Moderate, 4 Severe. Total score 0-5 Mild, 6-15 Moderate, 16-20 Severe.

Trial Locations

Locations (1)

Advanced Vision Care; 🇺🇸 Los Angeles, California, United States