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

NCT03489941 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2023-06-08

Study results available
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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

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.

Sponsors & Collaborators

  • ORA, Inc.

    collaborator INDUSTRY

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-07
Primary Completion
2018-04-29
Completion
2018-04-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03489941 on ClinicalTrials.gov