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.
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Wang Qin, Sobering Andrew K, Tirrito Christian, Haghshenas Sadegheh, Hjortshøj Tina Duelund, Platzer Konrad, Redler Silke, March Michael E, Matsuoka Leticia S, Xi Hang, Zoodsma Josiah, Chen Yuanhua, Mori Mari, Leung Marco L, Couque Nathalie, Verloes Alain, Pouzet Antoine, Giesbertz Noor Aa, Simon Marleen Eh, Yearwood Ashley K, Assing Dominique L, Hsieh Tzung-Chien, Li Jing-Mei, Levy Michael A, Kerkhof Jennifer, McConkey Haley, Rzasa Jessica, Lauzon-Young Carolyn, Sulaiman Raashda A, Abdulwahab Firdous, Shamseldin Hanan E, Almontashiri Naif Am, Afqi Manal, Vedanarayanan Vettaikorumakankav, Guillen Sacoto Maria J, Wentzensen Ingrid M, Damseh Nadirah S, Birnbaum Rivka, van Ommeren Babeth, Hopman Saskia Mj, Zaki Maha S, Elmakkawy Gehad, Afzal Erum, Kim JiHye, Efthymiou Stephanie, Houlden Henry, Nusrat Ambreen, Toft Mathias, Abdullah Uzma, Iqbal Zafar, Terek Shannon, Alkuraya Fowzan S, Bhoj Elizabeth J, Maroofian Reza, Sadikovic Bekim, Hakonarson Hakon, Song Yuanquan, Li Dong
Аннотация
Purpose: 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.