NCT03489941

A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle

A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle in the Treatment of Ocular Itching Associated With Allergic Conjunctivitis as Induced by the Conjunctival Allergen Challenge Model (Ora-CAC®)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the treatment of ocular itching.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	EM-100	Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
DRUG	Zaditor®	Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
DRUG	Vehicle	Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.

Timeline

• Start date: 2018-04-07
• Primary completion: 2018-04-29
• Completion: 2018-04-29
• First posted: 2018-04-06
• Last updated: 2023-06-08
• Results posted: 2021-05-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study