A Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution in Subjects With Mild or Moderate Myopia (APPLE)

Study Overview
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Brief Summary
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To investigate the safety and efficacy of three concentrations of DE-127 ophthalmic solution when compared to Placebo in subjects diagnosed with mild or moderate myopia. To investigate the dose response of DE-127.

Official Title
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A Phase II, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution Compared With Placebo in Subjects With Mild or Moderate Myopia (APPLE)

Conditions
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Myopia

Intervention / Treatment
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* Drug: DE-127 Ophthalmic Solution low dose
* Drug: DE-127 Ophthalmic Solution medium dose
* Drug: DE-127 Ophthalmic Solution high dose
* Drug: Placebo Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Refractive error of spherical equivalent -1.0 diopter to -6.0 diopter in both eyes Anisometropia of spherical equivalent less than or equal to 1.50 diopter in both eyes Distance vision correctable to logMAR 0.2 or better in both eyes Normal intraocular pressure of not greater than 21 mmHg in both eyes No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride Exclusion Criteria: Amblyopia or manifest strabismus including intermittent tropia Ocular disorders that potentially affect myopia or refractive power Previous or current use of contact lenses, bifocal lenses, progressive addition lenses, or other forms of treatment (including atropine and pirenzepine) for myopia Systemic disorders that potentially affect myopia or refractive power

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 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: DE-127 Ophthalmic Solution low dose<br> | Drug: DE-127 Ophthalmic Solution low dose<br>* Low dose of DE-127 Ophthalmic Solution dosed once daily for 12 months<br>|
| Experimental: DE-127 Ophthalmic Solution medium dose<br> | Drug: DE-127 Ophthalmic Solution medium dose<br>* Medium dose of DE-127 Ophthalmic Solution dosed once daily for 12 months<br>|
| Experimental: DE-127 Ophthalmic Solution high dose<br> | Drug: DE-127 Ophthalmic Solution high dose<br>* High dose of DE-127 Ophthalmic Solution dosed once daily for 12 months<br>|
| Placebo Comparator: Placebo Ophthalmic Solution<br> | Drug: Placebo Ophthalmic Solution<br>* Placebo Ophthalmic Solution dosed once daily for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spherical equivalent | Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at Month 12 in the study eye. | Month 12 |