Title
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®)
Phase
Phase 3Lead Sponsor
LEH PharmaStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Allergic ConjunctivitisStudy Participants
65A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the treatment of ocular itching.
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
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
| Event Type | Organ System | Event Term |
|---|
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.
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).
