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| ID | Type | Description | Link |
|---|---|---|---|
| 96015755 | Other Grant/Funding Number | Alcon Vision, LLC |
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The primary objective of this study is to determine if the addition of Rocklatan post-Hydrus will provide additional intraocular pressure lowering.
The study is a prospective single-practice with multiple locations, single-surgeon, parallel double arm study in subjects with open angle glaucoma (OAG), who were implanted with Hydrus microstent combined with cataract surgery to be randomized to receive Rocklatan vs. Comparator (artificial tears). Unmedicated MDIOP (mean diurnal intraocular pressure) measurements will be assessed at baseline (after Hydrus, prior to study medication) and at 1-month post-initiation of Study Drop.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Comparator Systane Artificial Tears | Placebo Comparator | Comparator arm is Systane artificial tears |
|
| FDA Approved Rocklatan (netarsudil 0.02% and latanoprost 0.005%) | Active Comparator | FDA approved Rocklatan (netarsudil 0.02% and latanoprost 0.005%) is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin analogue indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocklatan (netarsudil 0.02% and latanoprost 0.005%) | Drug | Additional intraocular eye pressure lowering post-Hydrus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean diurnal intraocular pressure change from baseline | After Hydrus prior to study initiation drop | After 28 days up to 35 days post initiation of Rocklatan vs placebo comparator |
| Measure | Description | Time Frame |
|---|---|---|
| Diurnal Intraocular pressure change from baseline and difference between intraocular pressure at each time point | Goldmann Applanation Tonometry | After Hydrus prior to study drop and after 28 days up to 35 days post initiation of study drop for all time points 8am, 10am, 4pm (± 1 hour) between groups |
| Measure | Description | Time Frame |
|---|---|---|
| Change in corneal hysteresis from baseline | Ocular Response Analyzer | Change from baseline after 28 days up to 35 days post initiation of study drop |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | Contact | 702-724-2005 | jodi.kennedy@c4slv.com | |
| Clinical Research Coordinator | Contact | 702-724-2067 |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director, Medical Doctor | Center For Sight | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Sight | Las Vegas | Nevada | 89145 | United States |
We do not plan to share individual participant data due to concerns about participant privacy and confidentiality.
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000603944 | netarsudil |
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| Systane | Drug | Placebo Comparator (artificial tears) |
|