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

AVC-003

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

2023-06-01

2024-06-01

2024-06-01

Recruiting

Early phase I

100

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In patient who undergo cataract surgery, subjects will be randomized to 2 arms and be followed for a period of 3 months.\n\nArm 1- control group, 50 subjects will receive Prednisolone Acetate 1% QID x 2 weeks then BID x 2 weeks.\n\nArm 2 - study group, 50 subjects will receive Dextenza 0.4mg insert', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2023-07-24