NCT04711213

A Clinical Study to Assess the Efficacy and Safety of SED80 for Use in Cataract Surgery

A Phase 2 Clinical Study to Assess the Efficacy and Safety of SED80 for the Treatment of Inflammation and Pain Associated With Cataract Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: iDrop, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of four groups of dexamethasone ophthalmic suspension or placebo eye drops to determine if the drops decrease inflammation and pain inside the eye and are safe after cataract surgery.

Detailed description

"Patients undergoing traditional cataract surgery routinely develop inflammation and pain. This study will evaluate 4 arms of either dexamethasone or placebo.

Conditions

• Cataract in Inflammatory Ocular Disorders

Interventions

Type	Name	Description
DRUG	Dexamethasone Dose 1	Dexamethasone ophthalmic suspension dose 1
DRUG	Dexamethasone Dose 2	Dexamethasone ophthalmic suspension dose 2
DRUG	Placebo Dose 1	Placebo suspension dose 1
DRUG	Placebo Dose 2	Placebo suspension dose 2

Timeline

• Start date: 2020-09-14
• Primary completion: 2020-10-31
• Completion: 2020-11-15
• First posted: 2021-01-15
• Last updated: 2021-01-15

Locations

1 site across 1 country: El Salvador

Regulatory

• FDA-regulated drug study