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The objective of this study is to explore the safety and efficacy of SHJ002 Sterile Ophthalmic Solution relative to atropine in myopia control
SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHJ002 | Experimental | The assigned eyedrops will be instilled in both eyes once per day, one drop per application, 7 days a week, for 52 weeks. |
|
| Atropine | Active Comparator | The assigned eyedrops will be instilled in both eyes once per day, one drop per application, 7 days a week, for 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHJ002 | Drug | Topical ophthalmic |
| |
| Atropine |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the cycloplegic spherical equivalent (SE) | from baseline visit to the final visit, up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of axial length | from baseline visit to the final visit, up to 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Center for Advanced Vision Care Tanasbourne Vision Center | Hillsboro | Ohio | 97124 | United States | ||
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| ID | Term |
|---|---|
| D047728 | Myopia, Degenerative |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D001285 | Atropine |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Drug |
Topical ophthalmic |
|
| Changhua Christian Hospital |
| Chang-hua |
| Taiwan |
| Kaohsiung Veterans General Hospital | Kaohsiung City | 813 | Taiwan |
| Chang Cung Memorial Hospital-Tucheng | New Taipei City | 236 | Taiwan |
| MacKay Memorial Hospital-Tamsui | New Taipei City | 251 | Taiwan |
| Chung Shan Medical University Hospital | Taichung | 402 | Taiwan |
| Cathay General Hospital | Taipei | 106 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 201 | Taiwan |
| Tri-Service General Hospital | Taipei | Taiwan |
| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |