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

Overview

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

Full Title of Study: “Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt in Conjunction With OMNI Drops Treating Pain, and inflamMation Following Cataract Surgery Compared to Topical Omni Drops.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2023

Detailed Description

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt in Conjunction With Topical Prednisolone phosphate 1% Treating Pain, and inflamMation Following Cataract Surgery Compared to Topical Prednisolone Phosphate 1%.

Interventions

  • Drug: Dextenza 0.4Mg Ophthalmic Insert
    • DEXTENZA 0.4Mg Ophthalmic Insert is a corticosteroid 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. Omni (yellow top) Prednisolone Phosphate 1%/Moxifloxacin 0.5%/Bromfenac 0.075%
  • Drug: Prednisolone Phosphate 1%/Moxifloxacin 0.5%/Bromfenac 0.075% compound
    • Omni (yellow top) Prednisolone Phosphate 1%/Moxifloxacin 0.5%/Bromfenac 0.075% is a compound gtt of: corticosteroid (to decrease inflammation), Antibiotic (to prevent infection) and NSAID (to decrease inflammation, swelling and pain). All of which are being used as a topical drop after cataract surgery as Standard Of Care.

Arms, Groups and Cohorts

  • Active Comparator: Arm 1 – Cataract surgery gtt regimen per SOC
    • Following cataract surgery patients will receive compound drop: Omni (yellow top) Prednisolone Phosphate 1%/Moxifloxacin 0.5%/Bromfenac 0.075% QID X 2 Weeks, then BID x 2 weeks and stop.
  • Experimental: Arm 2 – Cataract surgery with Dextenza and less frequency of gtt regimen
    • Following cataract surgery with DEXTENZA, patients will receive compound drop: Omni (yellow top) Prednisolone Phosphate 1%/Moxifloxacin 0.5%/Bromfenac 0.075% BID x 2 weeks, then QD x 2 weeks and stop.

Clinical Trial Outcome Measures

Primary Measures

  • 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 (4) mean a worse outcome.
  • 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

Secondary Measures

  • 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.
  • Absence of CME (Cystoid Macular Edema)
    • Time Frame: Assessed on Day 90
    • Measured by OCT (Optical Coherence Tomography)
  • 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 (4) mean a worse outcome.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nicole Fram M.D.
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Nicole Fram M.D., CEO – Advanced Vision Care
  • Overall Official(s)
    • Nicole R Fram, M.D., Principal Investigator, Advanced Vision Care
  • Overall Contact(s)
    • Nicole R Fram, M.D., 310-229-1220, nicfram@yahoo.com

References

Greenwood MD, Gorham RA, Boever KR. A Randomized Fellow-Eye Clinical Trial to Evaluate Patient Preference for Dexamethasone Intracanalicular Insert or Topical Prednisolone Acetate for Control of Postoperative Symptoms Following Bilateral Femtosecond Laser in Site Keratomileusis (LASIK). Clin Ophthalmol. 2020 Aug 6;14:2223-2228. doi: 10.2147/OPTH.S265311. eCollection 2020.

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. Erratum in: J Cataract Refract Surg. 2019 Jun;45(6):895.

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