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

Nicole Fram M.D.

Status and phase: Completed; Phase 4

Conditions: Corneal Edema; Ocular Pain; CME - Cystoid Macular Edema; Visual Outcome; Anterior Chamber Inflammation; Corneal Defect; Corneal Staining

Treatments: Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Prednisolone Acetate 1% Oph Susp; Drug: Prolensa 0.07% Ophthalmic Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05626478

AVC-003

Details and patient eligibility

About

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

Full description

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

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Arm 1 - Cataract surgery gtt regimen per SOC

Active Comparator group

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.

Treatment:

Drug: Prolensa 0.07% Ophthalmic Solution

Drug: Prednisolone Acetate 1% Oph Susp

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

Experimental group

Description:

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

Treatment:

Drug: Prolensa 0.07% Ophthalmic Solution

Drug: Dextenza 0.4Mg Ophthalmic Insert