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Completed

NCT Number: NCT05626478

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

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

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Key information

Conditions

Corneal Edema Anterior Chamber Inflammation CME - Cystoid Macular Edema Corneal Defect Corneal Diseases Corneal Staining Eye Diseases Eye Manifestations Eye Pain Macular Degeneration Macular Edema Neurologic Manifestations Ocular Pain Pain Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Signs and Symptoms Visual Outcome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Advanced Vision Care

Los Angeles, California, 90067, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Dexamethasone 0.4mg

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.

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.

Primary outcomes

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

    Time frame: 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.

  2. Mean change in pain score

    Time frame: 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 outcomes

  1. Visual outcome (Best Corrected Visual Acuity)

    Time frame: 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.

  2. Absence of CME (Cystoid Macular Edema)

    Time frame: 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.

  3. Mean change in corneal staining

    Time frame: 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.

Other outcomes

  1. Safety endpoint: corneal or retinal edema

    Time frame: Assessed throughout 90-day study period

    Measured by slit lamp examination and supporting imaging and testing such as Pachymetry measured in micrometer (μm) or Macular OCT (Optical Coherence Tomography) measured in microns (μ). Higher scores (in comparison to preop measurements) mean a worse outcome.

  2. Safety endpoint: Signs of Rebound Iritis

    Time frame: Assessed throughout 90-day study period

    Measured by slit lamp examination and scored by SUN (Standardization on Uveitis Nomenclature) grading scale of Anterior chamber Cell and Flare presence. 0-4 score scale. Cell: 0-0.5 Absence, 1-2 Mild, 2-3 Moderate 4 Severe. Flare: 0-1 Absence, 2 Mild, 3 Moderate, 4 Severe. Higher scores mean a worse outcome. (specifically sub-grouped Blue vs. Brown eyed subjects)

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

    Time frame: Assessed throughout 90-day study period

    Measured by Applanation in millimeter Hg(Mercury), higher then 22mm Hg or lower then 10mm Hg mean a worse outcome and a need for rescue.

Sponsors and collaborators

Lead sponsor

Nicole Fram M.D.

Other

Registry information

Official study title

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt in Conjunction With Topical Drop Regimen Treating Pain and inflamMation Following Cataract Surgery Compared to SOC Topical Drop Regimen

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 23, 2022
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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