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

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nicole Fram M.D.
• Treatments: Bromfenac; Dexamethasone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Moxifloxacin; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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