Pharmacokinetics of Aqueous Dexamethasone

NCT ID: NCT04667507

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-06-22

Brief Summary

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

Conditions

Pharmacokinetics; Aqueous Dexamethasone; Inflammatory Cytokine Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dextenza (Group A)

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

Group Type: EXPERIMENTAL

Dexamethasone Ophthalmic implant

Intervention Type: DRUG

Dexamethasone ophthalmic insert 0.4 mg for intracanalicular use

Dextenza (Group B)

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

Group Type: EXPERIMENTAL

Dexamethasone Ophthalmic implant

Intervention Type: DRUG

Dexamethasone ophthalmic insert 0.4 mg for intracanalicular use

Dextenza (Group C)

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

Group Type: EXPERIMENTAL

Dexamethasone Ophthalmic implant

Intervention Type: DRUG

Dexamethasone ophthalmic insert 0.4 mg for intracanalicular use

Dextenza (Group D)

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

Group Type: EXPERIMENTAL

Dexamethasone Ophthalmic implant

Intervention Type: DRUG

Dexamethasone ophthalmic insert 0.4 mg for intracanalicular use

Dextenza (Group E)

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

Group Type: EXPERIMENTAL

Dexamethasone Ophthalmic implant

Intervention Type: DRUG

Dexamethasone ophthalmic insert 0.4 mg for intracanalicular use

Control

Will not receive Dextenza (dexamethasone ophthalmic insert 0.4mg)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dexamethasone Ophthalmic implant

Dexamethasone ophthalmic insert 0.4 mg for intracanalicular use

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

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

Medical Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Frank A Bucci, Jr., MD

Role: PRINCIPAL_INVESTIGATOR

Bucci Laser Vision Institute

Locations

Bucci Laser Vision

Wilkes-Barre, Pennsylvania, United States

Countries

United States

Other Identifiers

IIT-CYTODEX

Identifier Type: -

Identifier Source: org_study_id