Status:
COMPLETED
Pharmacokinetics of Aqueous Dexamethasone
Lead Sponsor:
Frank A. Bucci, Jr., M.D.
Conditions:
Pharmacokinetics
Aqueous Dexamethasone
Eligibility:
All Genders
55+ years
Phase:
PHASE4
Brief Summary
The study is being done to measure the absorption of the DEXTENZA implant and inflammation concentration levels in the eye.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2022
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04667507
Start Date
January 1 2021
End Date
June 22 2022
Last Update
October 21 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Bucci Laser Vision
Wilkes-Barre, Pennsylvania, United States, 18702