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A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine HCl ophthalmic solution when administered bilaterally, once daily for 30 days in participants with presbyopia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilocarpine HCl Ophthalmic Solution | Experimental |
| |
| Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pilocarpine HCl Ophthalmic Solution | Drug | Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Title: Percentage of Participants Gaining 3 Lines or More in Mesopic, High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) at Day 30, Hour 3 | Baseline (Day 1) to Day 30 (Hour 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and frequency of adverse events (AE) and serious adverse events (SAE) etc. | Through study completion, an average of 60 days | |
| Area under the plasma concentration time curve from time zero to the last measurable concentration(AUC0-t) | Day 1 and Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group officer | Contact | 86-0311-69085587 | ctr-contact@cspc.cn |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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For arm 1, patients received pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days.
For arm 2, patients received vehicle, one drop in each eye, once daily, for up to 30 days.
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| Vehicle | Drug | Vehicle, one drop in each eye, once daily, for up to 30 days. |
|
| Area under the plasma concentration-time curve from time zero to infinity(AUC0-inf) | Day 1 and Day 30 |
| Maximum plasma concentration(Cmax) | Day 1 and Day 30 |
| Time to maximum plasma concentration (Tmax) | Day 1 and Day 30 |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) | Day 1 and Day 30 |
| Apparent Terminal Elimination Half-Life (T1/2) | Day 1 and Day 30 |
| Apparent total body clearance (CL/F) | Day 1 and Day 30 |