A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle
| Status: | Completed |
|---|---|
| Conditions: | Allergy, Ocular |
| Therapuetic Areas: | Ophthalmology, Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2018 |
| Start Date: | March 9, 2018 |
| End Date: | April 29, 2018 |
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®)
A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the
treatment of ocular itching.
treatment of ocular itching.
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
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