helmholtzeyeinstituteРоссийский офтальмологический журналRussian Ophthalmological Journal2072-00762587-5760Real time Publishers10.21516/2072-0076-2023-16-4-69-80helmholtzeyeinstitute-1358Research ArticleКЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯCLINICAL STUDIESЭффективность и безопасность стартовой гипотензивной терапии латанопростом с оптимизированным составомEfficacy and safety of the initial hypotensive treatment with an optimized latanoprost compositionhttps://orcid.org/0000-0001-6922-0464ПетровС. Ю.PetrovS. Yu.

Сергей Юрьевич Петров — д-р мед. наук, начальник отдела глаукомы

ул. Садовая-Черногрязская, д. 14/19, Москва, 105062, Россия

Sergey Yu. Petrov — Dr. of Med. Sci., head of the glaucoma department

14/19, Sadovaya-Chernogryazskaya St., Moscow, 105062, Russia

glaucomatosis@gmail.comhttps://orcid.org/0000-0003-1527-9414ЯниЕ. В.YaniE. V.

Елена Владимировна Яни — канд. мед. наук, руководитель отдела инфекционных и аллергических заболеваний глаз

ул. Садовая-Черногрязская, д. 14/19, Москва, 105062, Россия

Elena V. Yani — Cand. of Med. Sci., head of the department of infectious and allergic eye diseases

14/19, Sadovaya-Chernogryazskaya St., Moscow, 105062, Russia

https://orcid.org/0000-0001-8381-2124ЖуравлеваА. Н.ZhuravlevaA. N.

Анастасия Николаевна Журавлева — канд. мед. наук, научный сотрудник отдела глаукомы

ул. Садовая-Черногрязская, д. 14/19, Москва, 105062, Россия

Anastasia N. Zhuravleva — Cand. of Med. Sci., researcher, glaucoma department

14/19, Sadovaya-Chernogryazskaya St., Moscow, 105062, Russia

https://orcid.org/0000-0001-9082-4537ФилипповаО. М.FilippovaO. M.

Ольга Маратовна Филиппова — канд. мед. наук, научный сотрудник отдела глаукомы

ул. Садовая-Черногрязская, д. 14/19, Москва, 105062, Россия

Olga M. Filippova — Cand. of Med. Sci., researcher, glaucoma department

14/19, Sadovaya-Chernogryazskaya St., Moscow, 105062, Russia

КалининаО. М.KalininaO. M.

Ольга Михайловна Калинина — канд. мед. наук, заведующая отделом глаукомы

ул. Садовая-Черногрязская, д. 14/19, Москва, 105062, Россия

Olga M. Kalinina — Cand. of Med. Sci., head of glaucoma unit

14/19, Sadovaya-Chernogryazskaya St., Moscow, 105062, Russia

https://orcid.org/0000-0002-9991-5600ЯкубоваЛ. В.YakubovaL. V.

Лия Вагизовна Якубова — канд. мед. наук, старший научный сотрудник отдела глаукомы

ул. Садовая-Черногрязская, д. 14/19, Москва, 105062, Россия

Lia V. Yakubova — Cand. of Med. Sci., senior researcher, glaucoma department

14/19, Sadovaya-Chernogryazskaya St., Moscow, 105062, Russia

https://orcid.org/0000-0002-6180-960XКосакянС. М.KosakyanS. M.

Србуи Мкртумовна Косакян — канд. мед. наук, врач-офтальмолог отдела глаукомы

ул. Садовая-Черногрязская, д. 14/19, Москва, 105062, Россия

Srbui M. Kosakyan — Cand. of Med. Sci., ophthalmologist, glaucoma department

14/19, Sadovaya-Chernogryazskaya St., Moscow, 105062, Russia

ВасиленковаЛ. В.VasilenkovaL. V.

Любовь Васильевна Василенкова — канд. мед. наук, научный сотрудник отдела глаукомы

ул. Садовая-Черногрязская, д. 14/19, Москва, 105062, Россия

Ljubov V. Vasilenkova — Cand. of Med. Sci., researcher, glaucoma department

14/19, Sadovaya-Chernogryazskaya St., Moscow, 105062, Russia

МанукянИ. В.ManukyanI. V.

Инесса Вартановна Манукян — канд. мед. наук, врач-офтальмолог дневного стационара

ул. Садовая-Черногрязская, д. 14/19, Москва, 105062, Россия

Inessa V. Manukyan — Cand. of Med. Sci., day hospital ophthalmologist

14/19, Sadovaya-Chernogryazskaya St., Moscow, 105062, Russia

ФГБУ «НМИЦ глазных болезней им. Гельмгольца» Минздрава РоссииРоссияHelmholtz National Medical Research Center of Eye DiseasesRussian Federation2023291220231646980Copyright © Петров С.Ю., Яни Е.В., Журавлева А.Н., Филиппова О.М., Калинина О.М., Якубова Л.В., Косакян С.М., Василенкова Л.В., Манукян И.В., 20232023Петров С.Ю., Яни Е.В., Журавлева А.Н., Филиппова О.М., Калинина О.М., Якубова Л.В., Косакян С.М., Василенкова Л.В., Манукян И.В.Petrov S.Y., Yani E.V., Zhuravleva A.N., Filippova O.M., Kalinina O.M., Yakubova L.V., Kosakyan S.M., Vasilenkova L.V., Manukyan I.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://roj.igb.ru/jour/article/view/1358

Цель работы — сравнительное исследование эффективности и безопасности применения лекарственного препарата Латанопрост-Оптик с новым составом вспомогательных веществ и оригинального препарата латанопроста в стартовой терапии у пациентов с первичной открытоугольной глаукомой (ПОУГ).

Материал и методы

Материал и методы. Проведено проспективное, рандомизированное, сравнительное исследование 60 пациентов (71 глаз) с ПОУГ начальной и развитой стадий без предшествующей гипотензивной терапии. На скрининговом визите пациентов рандомизировали в основную (Латанопрост-Оптик) и контрольную (оригинальный препарат латанопроста) группы. Конечными точками являлись значения внутриглазного давления (ВГД), остроты зрения, периметрических индексов (MD, PSD), толщина слоя нервных волокон сетчатки, минимальная ширина нейроретинального пояска, толщина слоя нервных волокон сетчатки в макуле, толщина слоя ганглиозных клеток в макуле, толщина внутреннего плексиформного слоя, время разрыва слезной пленки, индекс OSDI, а также нежелательные явления. Период наблюдения составил 12 нед. ВГД измеряли в сроки 4 и 12 нед.

Результаты

Результаты. Среднее снижение ВГД в основной группе к концу наблюдения составило 32 % и ни в одной контрольной точке не имело статистически значимых различий с оригинальным препаратом. Отмечена недостоверная положительная динамика значений большинства функциональных параметров, что может указывать на наличие непрямого нейропротекторного действия. В основной группе отмечена положительная динамика времени разрыва слезной пленки и OSDI. По данным конфокальной микроскопии роговицы отрицательных изменений в динамике в основной группе не отмечено, в отличие от группы контроля. Зарегистрированы обратимые нежелательные явления — дискомфорт и покраснение бульбарной конъюнктивы слабой степени в обеих группах. Серьезных и системных нежелательных явлений не отмечено.

Заключение

Заключение. Препарат Латанопрост-Оптик обладает сопоставимой с оригинальным препаратом латанопроста гипотензивной эффективностью и высоким благоприятным профилем безопасности.

Purpose

Purpose: a comparative study of the efficacy and safety of Latanoprost-Optic, a new composition of excipients and the original latanoprost, in the initial therapy of primary open-angle glaucoma (POAG)

Material and methods

Material and methods. We performed a prospective, randomized, comparative study of 60 previously untreated patients (71 eyes) with early and advanced POAG stages. During the screening visit, patients were randomly divided into the main (Latanoprost-Optic) and the control (original latanoprost) groups. The target points included intraocular pressure (IOP), visual acuity, MD and PSD perimetry indices, RNFL thickness, MRW, NFL, GCL, IPL, tear film break time, OSDI, and adverse events. The observation period was 12 weeks. IOP was measured 4 and 12 weeks from observation start.

Results

Results. The average decrease in IOP in the study group by the end of the observation was 32% and did not show any statistically significant differences from the original drug at any control point. A positive unreliable dynamic of the values of most functional parameters was noted, which may indicate the presence of an indirect neuroprotective effect. In the study group, there was a positive trend in tear film rupture time and OSDI. According to corneal confocal microscopy, no negative changes in dynamics were noted, in contrast to the control group. Reversible discomfort and mild redness of the bulbar conjunctiva were recorded in both groups. No serious or systemic adverse events were noted.

Conclusion

Conclusion. Latanoprost-Optic has a hypotensive efficacy, comparable to the original latanoprost, and a high favorable safety profile.

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The authors declare that there are no conflicts of interest present.