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

Last updated: February 18, 2026
Sponsor: Nicole Fram M.D.
Overall Status: Completed

Phase

4

Condition

Anterior Uveitis

Eye Disease

Inflammation

Treatment

Prolensa 0.07% Ophthalmic Solution

Dextenza 0.4Mg Ophthalmic Insert

Prednisolone Acetate 1% Oph Susp

Clinical Study ID

NCT05626478
AVC-003
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with clinically significant cataract and are planning to undergonon-complicated Clear Cornea Incision Cataract Extraction with Posterior CapsuleIntraOcular 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

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 AcuityMeter 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 theoperated 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 alreadyspecified (e.g., systemic, behavioral, or other ocular disease/abnormality) if thehealth of the subject or the validity of the study outcomes may be compromised bythe subject's enrollment

Study Design

Total Participants: 50
Treatment Group(s): 3
Primary Treatment: Prolensa 0.07% Ophthalmic Solution
Phase: 4
Study Start date:
June 01, 2023
Estimated Completion Date:
February 05, 2025

Study Description

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

Connect with a study center

  • Advanced Vision Care

    Los Angeles, California 90067
    United States

    Site Not Available

  • Advanced Vision Care

    Los Angeles 5368361, California 5332921 90067
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.