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

iDrop, Inc.1 site in 1 country60 target enrollmentSeptember 14, 2020

ConditionsCataract in Inflammatory Ocular Disorders

InterventionsPlacebo Dose 2 Dexamethasone Dose 1 Dexamethasone Dose 2 Placebo Dose 1

DrugsDexamethasone Dose 1 Dexamethasone Dose 2 Placebo Dose 1 Placebo Dose 2

Overview

Phase: Phase 2
Intervention: Placebo Dose 2
Conditions: Cataract in Inflammatory Ocular Disorders
Sponsor: iDrop, Inc.
Enrollment: 60
Locations: 1
Primary Endpoint: Ocular inflammation
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 14, 2020

End Date

November 15, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel