Pharmacokinetics of Aqueous Dexamethasone

• Status: Enrolling by invitation
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is being done to measure the absorption of the DEXTENZA implant and inflammation concentration levels in the eye.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Frank A. Bucci, Jr., M.D.
• Treatments: Dexamethasone

Criteria

Inclusion Criteria:

• Male of female, aged 55 or older

• Scheduled to undergo phacoemulsification with the intraocular lens (IOL) implantation for the treatment of cataract

• Willing to comply with study instructions, agree to make study appointments, and complete the course of the study

• Must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate

Exclusion Criteria:

• Known allergy or contraindication to the test article or its components

• Presence of any ocular abnormality or significant illness that, in the investigator's opinion, could affect the subject's health

• History of any illness that could be expected to interfere with the study

• Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or study

• May not be currently using topical or systemic steroids or NSAIDs during the course of the study or within 4 weeks prior to enrolling in the study other than Dextenza and Omidria

• Subject has active corneal, conjunctival, or canalicular infections, including:

• Epithelial herpes simplex keratitis (dendritic keratitis)

• Vaccini

• Varicella

• Mycobacterial infections

• Fungal diseases of the eye

• Dacryocystitis