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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DE-127 Ophthalmic Solution low dose | Experimental |
| |
| DE-127 Ophthalmic Solution medium dose | Experimental |
| |
| DE-127 Ophthalmic Solution high dose | Experimental |
| |
| Placebo Ophthalmic Solution | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DE-127 Ophthalmic Solution low dose | Drug | Low dose of DE-127 Ophthalmic Solution dosed once daily for 12 months |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore National Eye Centre | Singapore | Singapore |
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| DE-127 Ophthalmic Solution medium dose | Drug | Medium dose of DE-127 Ophthalmic Solution dosed once daily for 12 months |
|
| DE-127 Ophthalmic Solution high dose | Drug | High dose of DE-127 Ophthalmic Solution dosed once daily for 12 months |
|
| Placebo Ophthalmic Solution | Drug | Placebo Ophthalmic Solution dosed once daily for 12 months |
|
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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