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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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A randomized, single-site, parallel-group, prospective study of patients who are candidates for SLT, to study the effect of IOP change with Rocklatan vs artificial tears.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rocklatan | netarsudil and latanoprost ophthalmic solution 0.02%/0.005% |
| |
| Systane Ultra | artificial tears |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocklatan | Drug | netarsudil and latanoprost ophthalmic solution 0.02%/0.005% |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean diurnal IOP | 6 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean diurnal IOP from baseline | 28 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who reach >20% IOP reduction from baseline | 6 weeks of treatment | |
| Number of IOP spikes | IOP spike defined as IOP 50% above baseline | 6 weeks of treatment |
Inclusion Criteria:
Patients 18 years and older
Documented diagnosis of mild to moderate primary open angle glaucoma or ocular hypertension. Diagnosis of primary open angle glaucoma must be supported by the following:
24-2 SITA faster within the last 6 months
- With a mean deviation of 0 to -12 dB, excluding patients that meet severe criteria by having defects involving fixation or in two hemispheres.
OCT RNFL and optic nerve examination within the last 6 months
Candidate for bilateral SLT
Post-washout, post-SLT IOPs between 28-10
Gonioscopy findings of Schafer grade III and IV
Exclusion Criteria:
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Adult patients who are a candidate for bilateral SLT.
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| Name | Affiliation | Role |
|---|---|---|
| Kingsley Okafor, MD | Colorado Ophthalmology Associates PC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Ophthalmology Associates PC | Denver | Colorado | 50210 | United States |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Systane Ultra |
| Drug |
artificial tears |
|