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

Corneal Edema Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05626478
• Other study ID #: AVC-003
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: July 2023
• Source: Advanced Vision Care
• Contact: Nicole R Fram, M.D.
• Phone: 310-229-1220
• Email: nicfram[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Chamber Inflammation
• Cataract
• Corneal Defect
• Corneal Edema
• Corneal Staining
• Edema
• Inflammation
• Macular Edema
• Ocular Pain
• Visual Outcome

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Advanced Vision Care	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Nicole Fram M.D.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety endpoint: corneal or retinal edema	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
Other	Safety endpoint: Signs of Rebound Iritis	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
Other	Safety endpoint: Change in IOP (IntraOcular Pressure) initiating rescue medications	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
Primary	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.	Assessed on Days 1,7,30,90
Primary	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	Assessed on Day 1,7, 30 and 90
Secondary	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.	Assessed on Day 1,7, 30 and 90
Secondary	Absence of CME (Cystoid Macular Edema)	Measured by OCT (Optical Coherence Tomography)	Assessed on Day 90
Secondary	Mean change in corneal staining	measured by the National Eye Institute 0-4 score scale, higher scores (4) mean a worse outcome.	Assessed on Day 7, 30 and 90

External Links

•   Dextenza [package insert]. Bedford, MA: Ocular Therapeutix, Inc; 2019