Dextenza Within Upper Lid Canaliculus Compared With Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With PCIOL.

• Status: Recruiting
• Trial end date: 2021-03-11
• Target enrollment: 0
• Participant gender: All

Summary

Assessing DEXTENZA efficacy when placed within the upper eyelid canaliculus as opposed to the lower eyelid canaliculus.

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

Details

• Lead Sponsor: Kerry Assil, MD
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Been diagnosed with clinically significant cataract and CE/PCIOL has been planned

• Bilateral cataract surgery with IOL has been planned

• Willing and able to comply with clinic visits and study related procedures

• Willing and able to sign the informed consent form

Exclusion Criteria:

• Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)

• Active infectious systemic disease

• Active infectious ocular or extraocular disease

• Obstructed nasolacrimal duct in the study eye(s)

• Hypersensitivity to dexamethasone

• Patients being treated with immunomodulating agents in the study eye(s)

• History of prior ocular surgery, excluding Lasik or PRK

• History of ocular inflammation or macular edema

• Use of any systemic NSAIDs greater than 375 mg per day

• Patients being treated with immunosuppressants and/or oral steroids

• Patients with a corticosteroid implant (i.e. Ozurdex)

• Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator