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| Name | Class |
|---|---|
| Alcon, a Novartis Company | INDUSTRY |
| Florida Eye Specialists | UNKNOWN |
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The purpose of this study is to collect data about how Rhopressa affects IOP in patients who have had an SLT procedure in both eyes.
This is a prospective, randomized, double-masked, placebo controlled (artificial tears), single center study. The study population will include seventy (n=70) subjects with POAG or ocular hypertension who have undergone SLT and may benefit from additional IOP reduction. If individuals are a candidate for treatment with Rhopressa (netarsudil) 0.02% ophthalmic solution post-SLT, they can potentially be included in the trial. The study duration per subject is expected to be 6 weeks (or up to 12 weeks if washout is required for previous IOP lowering treatment) with three scheduled study visits.
While both Rhopressa and 360 degrees SLT primarily target the trabecular meshwork, potential synergistic effects of the two therapies on conventional aqueous outflow are not completely understood. This study will determine whether initiation of Rhopressa post-360 degrees SLT provides greater IOP reduction than 360 degrees SLT alone. This information will aid healthcare providers in selecting the best approach to management of IOP in patients who have recently undergone 360 degrees SLT and may benefit from additional IOP reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rhopressa | Experimental |
| |
| Artificial Tears | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Netarsudil ophthalmic solution 0.02% | Drug | Apply one drop in each eye every evening |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean diurnal intraocular pressure (IOP) | Between-group difference in change in mean diurnal IOP | 42 Days |
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| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure (IOP) reduction at 8am, 10am, and 4pm | Between-group difference in change in IOP at the 8am, 10am, and 4pm timepoints | 42 Days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Coast Institute for Research at Florida Eye Specialists | Jacksonville | Florida | 32256 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Stuart, Annie. "Drug Update: Vyzulta and Rhopressa." Glaucoma Clinical Update, 31 Aug. 2018. | ||
| 33733980 | Background | Zaman F, Gieser SC, Schwartz GF, Swan C, Williams JM. A multicenter, open-label study of netarsudil for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension in a real-world setting. Curr Med Res Opin. 2021 Jun;37(6):1011-1020. doi: 10.1080/03007995.2021.1901222. Epub 2021 Mar 27. | |
| 30862377 |
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Only IPD used in the results publication
When the trial starts until it ends data collection
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| Artificial tears | Drug | Apply one drop in each eye every evening |
|
| Background |
| Gazzard G, Konstantakopoulou E, Garway-Heath D, Garg A, Vickerstaff V, Hunter R, Ambler G, Bunce C, Wormald R, Nathwani N, Barton K, Rubin G, Buszewicz M; LiGHT Trial Study Group. Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial. Lancet. 2019 Apr 13;393(10180):1505-1516. doi: 10.1016/S0140-6736(18)32213-X. Epub 2019 Mar 9. |
| 12049574 | Background | Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK 2nd, Wilson MR, Gordon MO. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002 Jun;120(6):701-13; discussion 829-30. doi: 10.1001/archopht.120.6.701. |
| 33391921 | Background | Allison K, Patel D, Alabi O. Epidemiology of Glaucoma: The Past, Present, and Predictions for the Future. Cureus. 2020 Nov 24;12(11):e11686. doi: 10.7759/cureus.11686. |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |
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