Clinical Study to Assess the Efficacy and Safety of G238 Compared to Clotrimazole Otic Solution in the Treatment of Otomycosis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of G238 for the treatment of otomycosis

Official Title
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A Phase III, Multicenter, Randomized, Double-blind, Parallel Group, Active Treatment-controlled Study Assessing the Safety and Efficacy of G238 Compared to Clotrimazole 1% Otic Solution in Patients With Otomycosis

Conditions
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Otomycosis

Intervention / Treatment
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* Drug: G238
* Drug: Clotrimazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older. Clinical diagnosis of otomycosis where topical treatment is indicated. Exclusion Criteria: Other ear diseases.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G238<br>Five drops into the ear canal twice daily for 14 days | Drug: G238<br>* Five drops into the ear canal twice daily for 14 days<br>|
| Active Comparator: Clotrimazole<br>Five drops into the ear canal twice daily for 14 days | Drug: Clotrimazole<br>* Five drops into the ear canal twice daily for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With a Complete Response to Treatment | Efficacy will be assessed primarily by evaluation of the fungal culture, and the sum of signs and symptom scores (pruritus, otalgia, otorrhea and aural fullness obstruction to be scored as 0=absent; 1= mild; 2=moderate; 3=severe). The primary efficacy variable is the proportion of subjects with a negative culture for fungus, AND a signs and symptom score of 0 on Day 24. Response to the study treatment was classed according to the following definitions: Complete response: Negative fungal culture or presumed eradication on day 24, and sum score for signs and symptoms = 0 on day 24. Partial response: Negative culture or presumed eradication on day 24, and sum score for signs and symptoms = 1 or 2 on day 24. No response: Positive culture on day 24 or negative culture or presumed eradication and sum score for signs and symptoms > 2 on day 24. | Day 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Signs/ Symptoms | The secondary efficacy variables include: Proportion of subjects with signs and symptoms score of 0 at Day 15 Proportion of subjects with signs and symptoms score of 0 at Day 24 Proportion of subjects with a negative culture for fungus or presumed eradication (mycological cure) on Day 24. | 2 weeks and 4 weeks |