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

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

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

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