Trial | NCT04592081  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
Assessing DEXTENZA efficacy when placed within the upper eyelid canaliculus as opposed to the lower eyelid canaliculus.
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).
Study Started
Aug 01
2020
Primary Completion
Feb 01
2021
Anticipated
Study Completion
Mar 11
2021
Anticipated
Last Update
Oct 19
2020

Drug Dextenza 0.4Mg Ophthalmic Insert

Dextenza 0.4Mg Ophthalmic Insert

DEXTENZA placed within the upper canaliculus Experimental

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

DEXTENZA placed within the lower canaliculus Active Comparator

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

Criteria 

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
No Results Posted