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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

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Bausch + Lomb

Status and phase

Completed
Phase 3

Conditions

Allergic Conjunctivitis

Treatments

Drug: Vehicle
Drug: EM-100
Drug: Zaditor®

Study type

Interventional

Funder types

Industry

Identifiers

NCT03489941
17-100-0011

Details and patient eligibility

About

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

Enrollment

65 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • be at least 18 years old
  • have a positive history of allergic conjunctivitis and positive skin test reaction to allergens
  • be willing to avoid disallowed medications for the appropriate washout period and throughout the trial
  • be willing to avoid contact lens use
  • be willing to have a pregnancy test
  • must be able to read an eye chart from 10 feet away

Exclusion criteria

  • must not have any allergies to the study medications
  • must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
  • must not have used an investigational drug or device in the past 30 days or currently be enrolled in another investigational trial

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

65 participants in 3 patient groups

EM-100
Experimental group
Description:
One drop of EM-100 in either the right or left eye once on Day 1.
Treatment:
Drug: EM-100
Zaditor®
Experimental group
Description:
One drop of Zaditor® in either the right or left eye once on Day 1.
Treatment:
Drug: Zaditor®
Vehicle
Experimental group
Description:
One drop of Vehicle in either the right or left eye once on Day 1.
Treatment:
Drug: Vehicle

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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