Dextenza Within Upper Lid Canaliculus Compared With Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With PCIOL.

Kerry Assil, MD

Status and phase: Unknown; Phase 4

Conditions: Post-Surgical Ocular Pain; Post-Surgical Ocular Inflammation

Treatments: Drug: Dextenza 0.4Mg Ophthalmic Insert

Study type: Interventional

Funder types: Other

Identifiers

NCT04592081

The Assil Study

Details and patient eligibility

About

Assessing DEXTENZA efficacy when placed within the upper eyelid canaliculus as opposed to the lower eyelid canaliculus.

Full description

Randomized controlled clinical trial assessing the efficacy of DEXTENZA, sustained release dexamethasone 0.4 mg insert when placed within the upper eye lid canaliculus in comparison to the lower lid canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lens implant (CE/PCIOL).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Been diagnosed with clinically significant cataract and CE/PCIOL has been planned
• Bilateral cataract surgery with IOL has been planned
• Willing and able to comply with clinic visits and study related procedures
• Willing and able to sign the informed consent form

Exclusion criteria

• Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
• Active infectious systemic disease
• Active infectious ocular or extraocular disease
• Obstructed nasolacrimal duct in the study eye(s)
• Hypersensitivity to dexamethasone
• Patients being treated with immunomodulating agents in the study eye(s)
• History of prior ocular surgery, excluding Lasik or PRK
• History of ocular inflammation or macular edema
• Use of any systemic NSAIDs greater than 375 mg per day
• Patients being treated with immunosuppressants and/or oral steroids
• Patients with a corticosteroid implant (i.e. Ozurdex)
• Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

DEXTENZA placed within the upper canaliculus

Experimental group

Description:

Dextenza placed within the upper canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation.

Treatment:

Drug: Dextenza 0.4Mg Ophthalmic Insert

DEXTENZA placed within the lower canaliculus

Active Comparator group

Description:

Dextenza placed within the lower canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation.

Treatment:

Drug: Dextenza 0.4Mg Ophthalmic Insert