NCT04592081

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).

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Kerry Assil, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• Post-Surgical Ocular Pain
• Post-Surgical Ocular Inflammation

Interventions

Type	Name	Description
DRUG	Dextenza 0.4Mg Ophthalmic Insert	Dextenza 0.4Mg Ophthalmic Insert

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-02-01
• Completion: 2021-03-11
• First posted: 2020-10-19
• Last updated: 2020-10-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study