At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 65 enrolled
Drug / intervention
EM-100 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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®)
In Brief
A Phase 3 clinical trial evaluating EM-100, Zaditor®, and 1 other intervention for Allergic Conjunctivitis. Completed, enrolled 65 participants across 1 site.
Detailed Summary
A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the treatment of ocular itching.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Conjunctivitis
CountriesUnited States
CollaboratorsORA, Inc.
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedApr 2018
Enrollment StartApr 2018
Primary CompletionApr 2018
TodayJul 2026
First PostedApr 6, 2018
Enrollment StartApr 7, 2018
Primary CompletionApr 29, 2018
TodayJul 2, 2026
Enrollment to primary: 22 daysPosted 8.2 years ago
Interventions
EM-100drug
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.
Vehicledrug
Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.