Pharmacokinetics of Aqueous Dexamethasone

Frank A. Bucci, Jr., M.D.

Status and phase: Completed; Phase 4

Conditions: Aqueous Dexamethasone; Inflammatory Cytokine Response; Pharmacokinetics

Treatments: Drug: Dexamethasone Ophthalmic implant

Study type: Interventional

Funder types: Other

Identifiers

NCT04667507

IIT-CYTODEX

Details and patient eligibility

About

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

Enrollment: 102 patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 6 patient groups

Dextenza (Group A)

Experimental group

Description:

Dextenza (dexamethasone ophthalmic insert 0.4mg) 1-3 days prior to cataract surgery

Treatment:

Drug: Dexamethasone Ophthalmic implant

Dextenza (Group B)

Experimental group

Description:

Dextenza (dexamethasone ophthalmic insert 0.4mg) 6-8 days prior to surgery

Treatment:

Drug: Dexamethasone Ophthalmic implant

Dextenza (Group C)

Experimental group

Description:

Dextenza (dexamethasone ophthalmic insert 0.4mg) 13-15 days prior to surgery

Treatment:

Drug: Dexamethasone Ophthalmic implant

Dextenza (Group D)

Experimental group

Description:

Dextenza (dexamethasone ophthalmic insert 0.4mg) 19-23days prior to surgery

Treatment:

Drug: Dexamethasone Ophthalmic implant

Dextenza (Group E)

Experimental group

Description:

Dextenza (dexamethasone ophthalmic insert 0.4mg) 26-31 days prior to surgery

Treatment:

Drug: Dexamethasone Ophthalmic implant

Control

No Intervention group

Description:

Will not receive Dextenza (dexamethasone ophthalmic insert 0.4mg)