Phase 3
Completed N=130
A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle
Source: ClinicalTrials.gov NCT03489941 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Ocular Itching — 0.81; 0.79; 1.98; 1.09 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the treatment of ocular itching.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching |
0.81; 0.79; 1.98; 1.09; 1.04; 2.17 | — |
| SECONDARY Conjunctival Redness |
2.13; 2.14; 2.72; 2.25; 2.29; 2.61 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03489941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.