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

July 21, 2023 updated by: Nicole Fram M.D.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90067
        • Recruiting
        • Advanced Vision Care
        • Principal Investigator:
          • Nicole Fram, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1 - Cataract surgery gtt regimen per SOC
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
Prednisolone Acetate 1% is a corticosteroid (to decrease inflammation) and being used as a topical drop after cataract surgery per Standard Of Care.
Drug: Prolensa 0.07% Ophthalmic Solution
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.
Experimental: Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimen
Following cataract surgery with DEXTENZA 0.4mg insert, patients will receive: Prolensa 0.07% QD X 4 Weeks and stop
Drug: Prolensa 0.07% Ophthalmic Solution
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.
Drug: Dextenza 0.4Mg Ophthalmic Insert
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed on Days 1,7,30,90
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
Assessed on Day 1,7, 30 and 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed on Day 1,7, 30 and 90
Absence of CME (Cystoid Macular Edema)
Time Frame: Assessed on Day 90
Measured by OCT (Optical Coherence Tomography)
Assessed on Day 90
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.
Assessed on Day 7, 30 and 90

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (Optical Coherence Tomography)
Assessed throughout 90-day study period
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: 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. (specifically sub-grouped Blue vs. Brown eyed subjects)
Assessed throughout 90-day study period
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.
Assessed throughout 90-day study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nicole Fram M.D.

Investigators

  • Principal Investigator: Nicole R Fram, M.D., Advanced Vision Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

November 8, 2022

First Submitted That Met QC Criteria

November 15, 2022

First Posted (Actual)

November 23, 2022

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVC-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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