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

Primary Purpose

Corneal Edema, Corneal Defect, Anterior Chamber Inflammation

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dextenza 0.4Mg Ophthalmic Insert
Prednisolone Acetate 1% Oph Susp
Prolensa 0.07% Ophthalmic Solution
Sponsored by
Nicole Fram M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Advanced Vision CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm 1 - Cataract surgery gtt regimen per SOC

Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimen

Arm Description

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.

Following cataract surgery with DEXTENZA 0.4mg insert, patients will receive: Prolensa 0.07% QD X 4 Weeks and stop

Outcomes

Primary Outcome Measures

Mean change in anterior chamber inflammation (Cell and Flare) scores
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
Measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worst pain possible

Secondary Outcome Measures

Visual outcome (Best Corrected Visual Acuity)
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)
Measured by OCT (Optical Coherence Tomography)
Mean change in corneal staining
measured by the National Eye Institute 0-4 score scale, higher scores (4) mean a worse outcome.

Full Information

First Posted
November 8, 2022
Last Updated
July 21, 2023
Sponsor
Nicole Fram M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT05626478
Brief Title
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nicole Fram M.D.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Edema, Corneal Defect, Anterior Chamber Inflammation, Ocular Pain, Corneal Staining, Visual Outcome, CME - Cystoid Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
In patient who undergo cataract surgery, subjects will be randomized to 2 arms and be followed for a period of 3 months. Arm 1- control group, 50 subjects will receive Prednisolone Acetate 1% QID x 2 weeks then BID x 2 weeks. Arm 2 - study group, 50 subjects will receive Dextenza 0.4mg insert
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 - Cataract surgery gtt regimen per SOC
Arm Type
Active Comparator
Arm Description
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 Title
Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimen
Arm Type
Experimental
Arm Description
Following cataract surgery with DEXTENZA 0.4mg insert, patients will receive: Prolensa 0.07% QD X 4 Weeks and stop
Intervention Type
Drug
Intervention Name(s)
Dextenza 0.4Mg Ophthalmic Insert
Other Intervention Name(s)
Dexamethasone 0.4mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisolone Acetate 1% Oph Susp
Intervention Description
Prednisolone Acetate 1% is a corticosteroid (to decrease inflammation) and being used as a topical drop after cataract surgery per Standard Of Care.
Intervention Type
Drug
Intervention Name(s)
Prolensa 0.07% Ophthalmic Solution
Intervention Description
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 Outcome Measure Information:
Title
Mean change in anterior chamber inflammation (Cell and Flare) scores
Description
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.
Time Frame
Assessed on Days 1,7,30,90
Title
Mean change in pain score
Description
Measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worst pain possible
Time Frame
Assessed on Day 1,7, 30 and 90
Secondary Outcome Measure Information:
Title
Visual outcome (Best Corrected Visual Acuity)
Description
Measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart. 0-70 letter read score. higher scores mean a better outcome.
Time Frame
Assessed on Day 1,7, 30 and 90
Title
Absence of CME (Cystoid Macular Edema)
Description
Measured by OCT (Optical Coherence Tomography)
Time Frame
Assessed on Day 90
Title
Mean change in corneal staining
Description
measured by the National Eye Institute 0-4 score scale, higher scores (4) mean a worse outcome.
Time Frame
Assessed on Day 7, 30 and 90
Other Pre-specified Outcome Measures:
Title
Safety endpoint: corneal or retinal edema
Description
Measured by slit lamp examination and supporting imaging and testing such as Pachymetry measured in micrometer (μm) or Macular (Optical Coherence Tomography)
Time Frame
Assessed throughout 90-day study period
Title
Safety endpoint: Signs of Rebound Iritis
Description
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)
Time Frame
Assessed throughout 90-day study period
Title
Safety endpoint: Change in IOP (IntraOcular Pressure) initiating rescue medications
Description
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.
Time Frame
Assessed throughout 90-day study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole R Fram, M.D.
Phone
310-229-1220
Email
nicfram@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Orly Shiler
Phone
310-229-1220
Email
orlyjr@inorbit.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole R Fram, M.D.
Organizational Affiliation
Advanced Vision Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advanced Vision Care
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orly Shiler
Phone
310-229-1220
Email
orlyjr@inorbit.com
First Name & Middle Initial & Last Name & Degree
Nicole Fram, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32821083
Citation
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.
Results Reference
background
PubMed Identifier
30367938
Citation
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.
Results Reference
background
Links:
URL
http://www.dextenza.com/wp-content/uploads/2019/06/NDA-208742-S001-Dextenza-labeling-19Jun19.pdf
Description
Dextenza [package insert]. Bedford, MA: Ocular Therapeutix, Inc; 2019

Learn more about this trial

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

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