Comparison of clinical effects of two latanoprost 0.005% solutions (Xalatan® and Arulatan®) in primary open-angle glaucoma or ocular hypertensive patients: a randomized clinical trial
Rodrigo A Brant Fernandes,1 Luci Meire P Silva,1 Diego Torres Dias,1 Rafael Henrique Pereira,2 Rubens Belfort Jr,1,2 Tiago Santos Prata1–31Department of Ophthalmology and Visual Sciences, Federal University of São Paulo, São Paulo, SP, Brazil; 2IPEPO/Vision Institute...
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Dove Medical Press
2019
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oai:doaj.org-article:958c2adb33bb4fd4a59ec68033d14af22021-12-02T03:57:30ZComparison of clinical effects of two latanoprost 0.005% solutions (Xalatan® and Arulatan®) in primary open-angle glaucoma or ocular hypertensive patients: a randomized clinical trial1177-5483https://doaj.org/article/958c2adb33bb4fd4a59ec68033d14af22019-04-01T00:00:00Zhttps://www.dovepress.com/comparison-of-clinical-effects-of-two-latanoprost-0005-solutions-xalat-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Rodrigo A Brant Fernandes,1 Luci Meire P Silva,1 Diego Torres Dias,1 Rafael Henrique Pereira,2 Rubens Belfort Jr,1,2 Tiago Santos Prata1–31Department of Ophthalmology and Visual Sciences, Federal University of São Paulo, São Paulo, SP, Brazil; 2IPEPO/Vision Institute – SP, São Paulo, SP, Brazil; 3Department of Ophthalmology, Mayo Clinic, Jacksonville, FL, USAPurpose: To evaluate the therapeutic non-inferiority between two ophthalmic latanoprost 0.005% solutions (Arulatan®, [ALT] versus the reference drug Xalatan®, [XLT]) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH).Patients and methods: This was a 12-week Phase IV, experimental, randomized, parallel-group, double-masked clinical trial. Consecutive patients with POAG or OH from the Glaucoma Service of Instituto Paulista de Estudos e Pesquisas em Oftalmologia (São Paulo, Brazil) were enrolled between July and December 2017. The primary outcome of the study was an analysis of therapeutic non-inferiority between ALT versus XLT at 12 weeks, while secondary outcomes were mean intraocular pressure (IOP) change from baseline at 2, 6 and 12 weeks, mean IOP at 2, 6 and 12 weeks, and topical and systemic side effects. Statistical significance was set at P<0.05. Computerized analysis was performed using the R software, version 3.4.4.Results: A total of 45 patients were randomized to the two treatment groups: ALT (22) and XLT (23). A statistically significant reduction in IOP from baseline was observed in both treatment groups at all timepoints, while no statistically significant difference between groups was detected. By week 12, observed IOP reduction was −7.95 and −7.89 mmHg in the ALT and in the XLT groups, respectively (P=0.60). Treatment difference between the ALT and the XLT groups was −0.06 mm Hg (95% CI: −0.97, 0.85) and fell within the interval set for therapeutic non-inferiority. There was no statistically significant difference between the two groups in terms of safety profiles. The most commonly reported side effect was mild conjunctival/palpebral hyperemia.Conclusion: ALT was considered non-inferior to XLT in achieving a statistically significant reduction in IOP at 12 weeks in POAG and OH patients. No significant difference in the occurrence of side effects was found between both groups.Keywords: glaucoma, latanoprost, IOP reductionBrant Fernandes RASilva LMPDias DTPereira RHBelfort Jr RPrata TSDove Medical Pressarticleglaucomalatanoprostintraocular pressure reductionOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 13, Pp 679-684 (2019) |
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glaucoma latanoprost intraocular pressure reduction Ophthalmology RE1-994 |
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glaucoma latanoprost intraocular pressure reduction Ophthalmology RE1-994 Brant Fernandes RA Silva LMP Dias DT Pereira RH Belfort Jr R Prata TS Comparison of clinical effects of two latanoprost 0.005% solutions (Xalatan® and Arulatan®) in primary open-angle glaucoma or ocular hypertensive patients: a randomized clinical trial |
| description |
Rodrigo A Brant Fernandes,1 Luci Meire P Silva,1 Diego Torres Dias,1 Rafael Henrique Pereira,2 Rubens Belfort Jr,1,2 Tiago Santos Prata1–31Department of Ophthalmology and Visual Sciences, Federal University of São Paulo, São Paulo, SP, Brazil; 2IPEPO/Vision Institute – SP, São Paulo, SP, Brazil; 3Department of Ophthalmology, Mayo Clinic, Jacksonville, FL, USAPurpose: To evaluate the therapeutic non-inferiority between two ophthalmic latanoprost 0.005% solutions (Arulatan®, [ALT] versus the reference drug Xalatan®, [XLT]) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH).Patients and methods: This was a 12-week Phase IV, experimental, randomized, parallel-group, double-masked clinical trial. Consecutive patients with POAG or OH from the Glaucoma Service of Instituto Paulista de Estudos e Pesquisas em Oftalmologia (São Paulo, Brazil) were enrolled between July and December 2017. The primary outcome of the study was an analysis of therapeutic non-inferiority between ALT versus XLT at 12 weeks, while secondary outcomes were mean intraocular pressure (IOP) change from baseline at 2, 6 and 12 weeks, mean IOP at 2, 6 and 12 weeks, and topical and systemic side effects. Statistical significance was set at P<0.05. Computerized analysis was performed using the R software, version 3.4.4.Results: A total of 45 patients were randomized to the two treatment groups: ALT (22) and XLT (23). A statistically significant reduction in IOP from baseline was observed in both treatment groups at all timepoints, while no statistically significant difference between groups was detected. By week 12, observed IOP reduction was −7.95 and −7.89 mmHg in the ALT and in the XLT groups, respectively (P=0.60). Treatment difference between the ALT and the XLT groups was −0.06 mm Hg (95% CI: −0.97, 0.85) and fell within the interval set for therapeutic non-inferiority. There was no statistically significant difference between the two groups in terms of safety profiles. The most commonly reported side effect was mild conjunctival/palpebral hyperemia.Conclusion: ALT was considered non-inferior to XLT in achieving a statistically significant reduction in IOP at 12 weeks in POAG and OH patients. No significant difference in the occurrence of side effects was found between both groups.Keywords: glaucoma, latanoprost, IOP reduction |
| format |
article |
| author |
Brant Fernandes RA Silva LMP Dias DT Pereira RH Belfort Jr R Prata TS |
| author_facet |
Brant Fernandes RA Silva LMP Dias DT Pereira RH Belfort Jr R Prata TS |
| author_sort |
Brant Fernandes RA |
| title |
Comparison of clinical effects of two latanoprost 0.005% solutions (Xalatan® and Arulatan®) in primary open-angle glaucoma or ocular hypertensive patients: a randomized clinical trial |
| title_short |
Comparison of clinical effects of two latanoprost 0.005% solutions (Xalatan® and Arulatan®) in primary open-angle glaucoma or ocular hypertensive patients: a randomized clinical trial |
| title_full |
Comparison of clinical effects of two latanoprost 0.005% solutions (Xalatan® and Arulatan®) in primary open-angle glaucoma or ocular hypertensive patients: a randomized clinical trial |
| title_fullStr |
Comparison of clinical effects of two latanoprost 0.005% solutions (Xalatan® and Arulatan®) in primary open-angle glaucoma or ocular hypertensive patients: a randomized clinical trial |
| title_full_unstemmed |
Comparison of clinical effects of two latanoprost 0.005% solutions (Xalatan® and Arulatan®) in primary open-angle glaucoma or ocular hypertensive patients: a randomized clinical trial |
| title_sort |
comparison of clinical effects of two latanoprost 0.005% solutions (xalatan® and arulatan®) in primary open-angle glaucoma or ocular hypertensive patients: a randomized clinical trial |
| publisher |
Dove Medical Press |
| publishDate |
2019 |
| url |
https://doaj.org/article/958c2adb33bb4fd4a59ec68033d14af2 |
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