Pharmacokinetics of Aqueous Dexamethasone
Completed · Phase 4
Conditions studied: Pharmacokinetics, Aqueous Dexamethasone, Inflammatory Cytokine Response
In brief
The study is being done to measure the absorption of the DEXTENZA implant and inflammation concentration levels in the eye.
Key facts
- Study ID
- NCT04667507
- Run by
- Frank A. Bucci, Jr., M.D.
- People needed
- 102
- Starts
- 2021-01-01
- Expected to finish
- 2022-06-22
- Last updated by the study team
- 2024-10-21
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Bucci Laser Vision — Wilkes-Barre, Pennsylvania, United States
Full record on ClinicalTrials.gov
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