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Completed

NCT Number: 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 study to demonstrate the non-inferiority of EM-100 to Zaditor® in the treatment of ocular itching.

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EM-100

Drug

Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.

Zaditor®

Drug

Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.

Vehicle

Drug

Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.

Primary outcomes

  1. Ocular Itching

    Time frame: 3, 5 and 7 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1

    Ocular itching scores were self-assessed by the participant using a 5-point scale with 0.5 unit increments, wherein 0 = None (normal, no itching), 1.0 = Intermittent tickle sensation involving more than just the corner of the eye, 2.0 = Mild continuous itch without desire to rub, 3.0 = Severe itch with desire to rub, and 4.0 = Incapacitating itch with irresistible urge to rub.

Secondary outcomes

  1. Conjunctival Redness

    Time frame: 7, 15 and 20 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1

    The investigator assessed conjunctival redness scores using a 5-point scale with 0.5 unit increments, wherein 0 = None (normal, no dilated blood vessels), 1 = Mild (slightly dilated blood vessels: pink color; can be quadrantal), 2 = Moderate (more apparent dilation, with redder color, involving majority of the vessel bed), 3 = Severe (numerous and obvious dilated blood vessels, with deep red color and no color, or less red with chemosis), and 4 = Extremely Severe (large, numerous, dilated blood vessels characterized by unusually severe deep red color regardless of chemosis and involving the entire vessel bed).

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Collaborators

  • ORA, Inc.

Registry information

Official study title

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®)

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2018
Registry last updated
Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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