Clinical trial NCT05626478: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Corneal Edema
Corneal Defect
Anterior Chamber Inflammation
Ocular Pain
Corneal Staining
Visual Outcome
CME - Cystoid Macular Edema
Lead sponsor: Advanced Vision Care
Sponsor class: OTHER
First posted: 2022-11-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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, 25 subjects will receive Prednisolone Acetate 1% QID x 2 weeks then BID x 2 weeks.

Arm 2 - study group, 25 subjects will receive Dextenza 0.4mg insert
Primary purpose: TREATMENT

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%.

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

Primary outcomes:
measure: Mean change in anterior chamber inflammation (Cell and Flare) scores
timeFrame: Assessed on Days 1,7,30,90
measure: Mean change in pain score
timeFrame: Assessed on Day 1,7, 30 and 90
Secondary outcomes:
measure: Visual outcome (Best Corrected Visual Acuity)
timeFrame: Assessed on Day 1,7, 30 and 90
measure: Absence of CME (Cystoid Macular Edema)
timeFrame: Assessed on Day 90
measure: Mean change in corneal staining
timeFrame: Assessed on Day 7, 30 and 90
Other outcomes:
measure: Safety endpoint: corneal or retinal edema
timeFrame: Assessed throughout 90-day study period
measure: Safety endpoint: Signs of Rebound Iritis
timeFrame: Assessed throughout 90-day study period
measure: Safety endpoint: Change in IOP (IntraOcular Pressure) initiating rescue medications
timeFrame: Assessed throughout 90-day study period
Locations:
city: Los Angeles
country: United States
facility: Advanced Vision Care
state: California
Study officials:
affiliation: Advanced Vision Care
name: Nicole R Fram, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.