Phase 3 Clinical Trial Comparing the Safety and Efficacy of Netarsudil to Ripasudil in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: Japan Rho Kinase Elevated Intraocular Pressure Treatment Trial (J-ROCKET)
Introduction A clinical trial evaluated ocular hypotensive efficacy and safety of netarsudil 0.02% once daily (QD) relative to ripasudil 0.4% twice daily (BID). Methods This was a single-masked, randomized, phase 3, superiority study. Japanese patients were randomized to either the netarsudil 0.02%...
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| creator | Araie, Makoto Sugiyama, Kazuhisa Aso, Kenji Kanemoto, Koji Iwata, Ryo Hollander, David A. Senchyna, Michelle Kopczynski, Casey C. |
| description | Introduction
A clinical trial evaluated ocular hypotensive efficacy and safety of netarsudil 0.02% once daily (QD) relative to ripasudil 0.4% twice daily (BID).
Methods
This was a single-masked, randomized, phase 3, superiority study. Japanese patients were randomized to either the netarsudil 0.02% group or the ripasudil 0.4% group in a 1:1 ratio and treated for 4 weeks. The primary efficacy variable was mean diurnal intraocular pressure (IOP) (average of diurnal time points at 09:00, 11:00, and 16:00) at Week 4.
Results
A total of 245 patients were included in the primary analysis. At Week 4, least squares (LS) mean of diurnal IOP adjusted for baseline was 15.96 and 17.71 mmHg in the netarsudil 0.02% and ripasudil 0.4% groups, respectively, demonstrating the superiority of netarsudil 0.02% QD over ripasudil 0.4% BID by a margin of − 1.74 mmHg (
p
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| doi_str_mv | 10.1007/s12325-023-02550-w |
| format | Article |
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A clinical trial evaluated ocular hypotensive efficacy and safety of netarsudil 0.02% once daily (QD) relative to ripasudil 0.4% twice daily (BID).
Methods
This was a single-masked, randomized, phase 3, superiority study. Japanese patients were randomized to either the netarsudil 0.02% group or the ripasudil 0.4% group in a 1:1 ratio and treated for 4 weeks. The primary efficacy variable was mean diurnal intraocular pressure (IOP) (average of diurnal time points at 09:00, 11:00, and 16:00) at Week 4.
Results
A total of 245 patients were included in the primary analysis. At Week 4, least squares (LS) mean of diurnal IOP adjusted for baseline was 15.96 and 17.71 mmHg in the netarsudil 0.02% and ripasudil 0.4% groups, respectively, demonstrating the superiority of netarsudil 0.02% QD over ripasudil 0.4% BID by a margin of − 1.74 mmHg (
p
< 0.0001). Mean reduction from baseline in mean diurnal IOP at Week 4 was 4.65 and 2.98 mmHg, respectively. Adverse events (AEs) occurred less frequently in netarsudil 0.02% than in ripasudil 0.4%, with the incidence of ocular AEs being 59.8% and 66.7%, respectively. The most frequently reported AE was conjunctival hyperemia in both groups, with an incidence of 54.9% and 62.6%, respectively. No serious eye-related AEs were reported.
Conclusion
Netarsudil ophthalmic solution 0.02% dosed QD (p.m.) was well tolerated and more effective in reducing IOP than ripasudil ophthalmic solution 0.4% dosed BID. Netarsudil 0.02% QD may become an important option for the treatment of Japanese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).
Trial registration
ClinicalTrials.gov identifier, NCT04620135.</description><identifier>ISSN: 0741-238X</identifier><identifier>ISSN: 1865-8652</identifier><identifier>EISSN: 1865-8652</identifier><identifier>DOI: 10.1007/s12325-023-02550-w</identifier><identifier>PMID: 37603205</identifier><language>eng</language><publisher>Cheshire: Springer Healthcare</publisher><subject>Cardiology ; Endocrinology ; Internal Medicine ; Medicine ; Medicine & Public Health ; NCT ; NCT04620135 ; Oncology ; Original Research ; Pharmacology/Toxicology ; Rheumatology</subject><ispartof>Advances in therapy, 2023-10, Vol.40 (10), p.4639-4656</ispartof><rights>The Author(s) 2023</rights><rights>2023. The Author(s).</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c424t-ca1256d87776b4508fc5c77a98e0ab914e396bf4c6349ca691fdce28bc95422b3</citedby><cites>FETCH-LOGICAL-c424t-ca1256d87776b4508fc5c77a98e0ab914e396bf4c6349ca691fdce28bc95422b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s12325-023-02550-w$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s12325-023-02550-w$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,27924,27925,41488,42557,51319</link.rule.ids></links><search><creatorcontrib>Araie, Makoto</creatorcontrib><creatorcontrib>Sugiyama, Kazuhisa</creatorcontrib><creatorcontrib>Aso, Kenji</creatorcontrib><creatorcontrib>Kanemoto, Koji</creatorcontrib><creatorcontrib>Iwata, Ryo</creatorcontrib><creatorcontrib>Hollander, David A.</creatorcontrib><creatorcontrib>Senchyna, Michelle</creatorcontrib><creatorcontrib>Kopczynski, Casey C.</creatorcontrib><title>Phase 3 Clinical Trial Comparing the Safety and Efficacy of Netarsudil to Ripasudil in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: Japan Rho Kinase Elevated Intraocular Pressure Treatment Trial (J-ROCKET)</title><title>Advances in therapy</title><addtitle>Adv Ther</addtitle><description>Introduction
A clinical trial evaluated ocular hypotensive efficacy and safety of netarsudil 0.02% once daily (QD) relative to ripasudil 0.4% twice daily (BID).
Methods
This was a single-masked, randomized, phase 3, superiority study. Japanese patients were randomized to either the netarsudil 0.02% group or the ripasudil 0.4% group in a 1:1 ratio and treated for 4 weeks. The primary efficacy variable was mean diurnal intraocular pressure (IOP) (average of diurnal time points at 09:00, 11:00, and 16:00) at Week 4.
Results
A total of 245 patients were included in the primary analysis. At Week 4, least squares (LS) mean of diurnal IOP adjusted for baseline was 15.96 and 17.71 mmHg in the netarsudil 0.02% and ripasudil 0.4% groups, respectively, demonstrating the superiority of netarsudil 0.02% QD over ripasudil 0.4% BID by a margin of − 1.74 mmHg (
p
< 0.0001). Mean reduction from baseline in mean diurnal IOP at Week 4 was 4.65 and 2.98 mmHg, respectively. Adverse events (AEs) occurred less frequently in netarsudil 0.02% than in ripasudil 0.4%, with the incidence of ocular AEs being 59.8% and 66.7%, respectively. The most frequently reported AE was conjunctival hyperemia in both groups, with an incidence of 54.9% and 62.6%, respectively. No serious eye-related AEs were reported.
Conclusion
Netarsudil ophthalmic solution 0.02% dosed QD (p.m.) was well tolerated and more effective in reducing IOP than ripasudil ophthalmic solution 0.4% dosed BID. Netarsudil 0.02% QD may become an important option for the treatment of Japanese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).
Trial registration
ClinicalTrials.gov identifier, NCT04620135.</description><subject>Cardiology</subject><subject>Endocrinology</subject><subject>Internal Medicine</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>NCT</subject><subject>NCT04620135</subject><subject>Oncology</subject><subject>Original Research</subject><subject>Pharmacology/Toxicology</subject><subject>Rheumatology</subject><issn>0741-238X</issn><issn>1865-8652</issn><issn>1865-8652</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><recordid>eNp9Uk2P0zAQjRCIXRb-ACcfl0PAcex8cEGrquynaFWKxM2auJPWq8TO2s5W_bv8ElxSIXHhMLZG896bGfslyfuMfswoLT_5jOVMpJTlMYSg6f5Fcp5VhUhjsJfJOS15lrK8-nmWvPH-kVJGS1G9Ts7ysqA5o-I8-bXcgUeSk1mnjVbQkbXT8ZzZfgCnzZaEHZLv0GI4EDAbMm_bCFMHYlvyDQM4P250R4IlKz3AlGhDlhA0muDJXocdWTrdgzuQxYAmvTLbDsl1B6OyPRDryEKNHThycxjQBTReW_OZ3MEAhqx2ltxrc5xx3uEzBNyQWxMc2ImzdOj96DCOjRD62PK0wOVdulrM7ufrD2-TVy10Ht-d7ovkx9f5enaTPiyub2dXD6nijIdUQcZEsanKsiwaLmjVKqHKEuoKKTR1xjGvi6blqsh5raCos3ajkFWNqgVnrMkvki-T7jA2PcbaccxODtPu0oKW_1aM3smtfZYZ5XVd8yoqXJ4UnH0a0QfZa6-w68CgHb1kleA5FyXPI5RNUOWs9w7bv30yKo_ukJM7ZHSH_OMOuY-kfCL54fi16OSjHZ2Jj_I_1m-xc8CV</recordid><startdate>20231001</startdate><enddate>20231001</enddate><creator>Araie, Makoto</creator><creator>Sugiyama, Kazuhisa</creator><creator>Aso, Kenji</creator><creator>Kanemoto, Koji</creator><creator>Iwata, Ryo</creator><creator>Hollander, David A.</creator><creator>Senchyna, Michelle</creator><creator>Kopczynski, Casey C.</creator><general>Springer Healthcare</general><scope>C6C</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20231001</creationdate><title>Phase 3 Clinical Trial Comparing the Safety and Efficacy of Netarsudil to Ripasudil in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: Japan Rho Kinase Elevated Intraocular Pressure Treatment Trial (J-ROCKET)</title><author>Araie, Makoto ; Sugiyama, Kazuhisa ; Aso, Kenji ; Kanemoto, Koji ; Iwata, Ryo ; Hollander, David A. ; Senchyna, Michelle ; Kopczynski, Casey C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c424t-ca1256d87776b4508fc5c77a98e0ab914e396bf4c6349ca691fdce28bc95422b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Cardiology</topic><topic>Endocrinology</topic><topic>Internal Medicine</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>NCT</topic><topic>NCT04620135</topic><topic>Oncology</topic><topic>Original Research</topic><topic>Pharmacology/Toxicology</topic><topic>Rheumatology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Araie, Makoto</creatorcontrib><creatorcontrib>Sugiyama, Kazuhisa</creatorcontrib><creatorcontrib>Aso, Kenji</creatorcontrib><creatorcontrib>Kanemoto, Koji</creatorcontrib><creatorcontrib>Iwata, Ryo</creatorcontrib><creatorcontrib>Hollander, David A.</creatorcontrib><creatorcontrib>Senchyna, Michelle</creatorcontrib><creatorcontrib>Kopczynski, Casey C.</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Advances in therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Araie, Makoto</au><au>Sugiyama, Kazuhisa</au><au>Aso, Kenji</au><au>Kanemoto, Koji</au><au>Iwata, Ryo</au><au>Hollander, David A.</au><au>Senchyna, Michelle</au><au>Kopczynski, Casey C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase 3 Clinical Trial Comparing the Safety and Efficacy of Netarsudil to Ripasudil in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: Japan Rho Kinase Elevated Intraocular Pressure Treatment Trial (J-ROCKET)</atitle><jtitle>Advances in therapy</jtitle><stitle>Adv Ther</stitle><date>2023-10-01</date><risdate>2023</risdate><volume>40</volume><issue>10</issue><spage>4639</spage><epage>4656</epage><pages>4639-4656</pages><issn>0741-238X</issn><issn>1865-8652</issn><eissn>1865-8652</eissn><abstract>Introduction
A clinical trial evaluated ocular hypotensive efficacy and safety of netarsudil 0.02% once daily (QD) relative to ripasudil 0.4% twice daily (BID).
Methods
This was a single-masked, randomized, phase 3, superiority study. Japanese patients were randomized to either the netarsudil 0.02% group or the ripasudil 0.4% group in a 1:1 ratio and treated for 4 weeks. The primary efficacy variable was mean diurnal intraocular pressure (IOP) (average of diurnal time points at 09:00, 11:00, and 16:00) at Week 4.
Results
A total of 245 patients were included in the primary analysis. At Week 4, least squares (LS) mean of diurnal IOP adjusted for baseline was 15.96 and 17.71 mmHg in the netarsudil 0.02% and ripasudil 0.4% groups, respectively, demonstrating the superiority of netarsudil 0.02% QD over ripasudil 0.4% BID by a margin of − 1.74 mmHg (
p
< 0.0001). Mean reduction from baseline in mean diurnal IOP at Week 4 was 4.65 and 2.98 mmHg, respectively. Adverse events (AEs) occurred less frequently in netarsudil 0.02% than in ripasudil 0.4%, with the incidence of ocular AEs being 59.8% and 66.7%, respectively. The most frequently reported AE was conjunctival hyperemia in both groups, with an incidence of 54.9% and 62.6%, respectively. No serious eye-related AEs were reported.
Conclusion
Netarsudil ophthalmic solution 0.02% dosed QD (p.m.) was well tolerated and more effective in reducing IOP than ripasudil ophthalmic solution 0.4% dosed BID. Netarsudil 0.02% QD may become an important option for the treatment of Japanese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).
Trial registration
ClinicalTrials.gov identifier, NCT04620135.</abstract><cop>Cheshire</cop><pub>Springer Healthcare</pub><pmid>37603205</pmid><doi>10.1007/s12325-023-02550-w</doi><tpages>18</tpages><oa>free_for_read</oa></addata></record> |
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| source | SpringerLink Journals - AutoHoldings |
| subjects | Cardiology Endocrinology Internal Medicine Medicine Medicine & Public Health NCT NCT04620135 Oncology Original Research Pharmacology/Toxicology Rheumatology |
| title | Phase 3 Clinical Trial Comparing the Safety and Efficacy of Netarsudil to Ripasudil in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: Japan Rho Kinase Elevated Intraocular Pressure Treatment Trial (J-ROCKET) |
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