Overview

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