IF 2.6
3区 医学
Q2 OPHTHALMOLOGY
引用次数: 0
摘要
简介：本研究旨在评估羟丙基瓜儿胶-透明质酸（HPG-HA）双聚合物润滑滴眼液对印度干眼症（DED）患者的安全性和有效性：这项前瞻性、开放标签、单臂、IV 期研究在印度进行：纳入标准：平均眼表染色（TOSS）总分≥ 4 分、每只眼最佳矫正视力≥ 20/40、泪液破裂时间（TBUT）≤ 10 秒、干眼症问卷调查（DEQ-5）得分≥ 6 分的成年人（18-65 岁）。受试者在第1天滴入第一剂HPG-HA眼药水，并自行滴入1-2滴，每天4次，持续90±5天：主要终点：整个研究过程中治疗突发不良事件（TEAEs）的频率和特征，以及第 90 天时的 TOSS 评分。次要/其他终点：干眼症状评分（通过干眼症状问卷 [DEQ-5]）和 TBUT：175名受试者中有36人（20.6%）出现≥1次TEAE，其中27人（15.4%）报告出现≥1次轻度药物相关TEAE（眼刺激[n = 9]、眼瘙痒[n = 8]、视力模糊[n = 6]、流泪增多[n = 4]、眼部充血[n = 3]和眼部不适[n = 1]）。一名受试者因 TEAEs 而停药，没有人因此而中断用药。无严重不良事件报告。平均 TOSS 评分从第 1 天（6.12 ± 1.69，OU [双眼]）降低到第 90 天（2.40 ± 1.97，OU）。DEQ-5 平均得分从第 1 天（11.50 ± 2.27）降低到第 90 天（5.50 ± 2.50）。TBUT从第1天（右眼[OD]，5.70 ± 1.94；左眼[OS]，5.70 ± 1.96）增加到第90天（OD，9.51 ± 3.08；OS，9.63 ± 3.01）：HPG-HA双聚合物滴眼液对印度受试者90天内缓解DED症状安全有效：试验注册：印度临床试验注册中心，CTRI/2022/03/041175。本文章由计算机程序翻译，如有差异，请以英文原文为准。
Safety and Efficacy of Hydroxypropyl Guar-Hyaluronic Acid Dual-Polymer Lubricating Eye Drops in Indian Subjects with Dry Eye: A Phase IV Study.
Introduction: This work aimed to evaluate the safety and efficacy of hydroxypropyl guar-hyaluronic acid (HPG-HA) dual-polymer lubricating drops in Indian subjects with dry eye disease (DED).
Methods: This prospective, open-label, single-arm, phase IV study was conducted in India.
Inclusion criteria: Adults (18-65 years) with an average total ocular surface staining (TOSS) score ≥ 4, best-corrected visual acuity of ≥ 20/40 in each eye, tear break-up time (TBUT) ≤ 10 s, and dry eye questionnaire (DEQ-5) score ≥ 6. Subjects received the first dose of HPG-HA eye drops on day 1 and self-administered 1-2 drops four times daily for 90 ± 5 days.
Primary endpoints: Frequency and characteristics of treatment-emergent adverse events (TEAEs) throughout the study and TOSS score at day 90. Secondary/other endpoints: Dry eye symptoms score (through dry eye questionnaire [DEQ-5]) and TBUT.
Results: Of 175 subjects, 36 (20.6%) had ≥ 1 TEAE, and 27 (15.4%) of this reported ≥ 1 mild drug-related TEAE (eye irritation [n = 9], eye pruritus [n = 8], blurred vision [n = 6], increased lacrimation [n = 4], ocular hyperemia [n = 3], and ocular discomfort [n = 1]). One subject discontinued due to TEAEs, and none led to drug interruptions. No serious adverse events were reported. The mean TOSS score reduced from day 1 (6.12 ± 1.69, OU [both eyes]) to day 90 (2.40 ± 1.97, OU). The mean DEQ-5 score reduced from day 1 (11.50 ± 2.27) to day 90 (5.50 ± 2.50). TBUT increased from day 1 (right eye [OD], 5.70 ± 1.94; left eye [OS], 5.70 ± 1.96) to day 90 (OD, 9.51 ± 3.08; OS, 9.63 ± 3.01).
Conclusions: HPG-HA dual-polymer eye drop was safe and effective in relieving signs and symptoms of DED over 90 days in Indian subjects.
Trial registration: Clinical Trial Registry India, CTRI/2022/03/041175.
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来源期刊
Ophthalmology and Therapy
OPHTHALMOLOGY-
CiteScore
4.20
自引率
3.00%
发文量
157
审稿时长
6 weeks
期刊介绍：
Aims and Scope
Ophthalmology and Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from preclinical, clinical (all phases), observational, real-world, and health outcomes research around the use of ophthalmological therapies, devices, and surgical techniques.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Ophthalmology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals.
Rapid Publication
The journal’s publication timelines aim for a rapid peer review of 2 weeks. If an article is accepted it will be published 3–4 weeks from acceptance. The rapid timelines are achieved through the combination of a dedicated in-house editorial team, who manage article workflow, and an extensive Editorial and Advisory Board who assist with peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid, efficient communication of the latest research and reviews, fostering the advancement of ophthalmic therapies.
Open Access
All articles published by Ophthalmology and Therapy are open access.
Personal Service
The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning authors will always have an editorial contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research.
Digital Features and Plain Language Summaries
Ophthalmology and Therapy offers a range of additional features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by key summary points, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand the scientific content and overall implications of the article. The journal also provides the option to include various types of digital features including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations. All additional features are peer reviewed to the same high standard as the article itself. If you consider that your paper would benefit from the inclusion of a digital feature, please let us know. Our editorial team are able to create high-quality slide decks and infographics in-house, and video abstracts through our partner Research Square, and would be happy to assist in any way we can. For further information about digital features, please contact the journal editor (see ‘Contact the Journal’ for email address), and see the ‘Guidelines for digital features and plain language summaries’ document under ‘Submission guidelines’.
For examples of digital features please visit our showcase page https://springerhealthcare.com/expertise/publishing-digital-features/
Publication Fees
Upon acceptance of an article, authors will be required to pay the mandatory Rapid Service Fee of €5250/$6000/£4300. The journal will consider fee discounts and waivers for developing countries and this is decided on a case by case basis.
Peer Review Process
Upon submission, manuscripts are assessed by the editorial team to ensure they fit within the aims and scope of the journal and are also checked for plagiarism. All suitable submissions are then subject to a comprehensive single-blind peer review. Reviewers are selected based on their relevant expertise and publication history in the subject area. The journal has an extensive pool of editorial and advisory board members who have been selected to assist with peer review based on the afore-mentioned criteria.
At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials, and Letters which are generally reviewed by one member of the Editorial Board. Where reviewer recommendations are conflicted, the editorial board will be contacted for further advice and a presiding decision. Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed). Once a revised manuscript is re-submitted, it is assessed along with the responses to reviewer comments and if it has been adequately revised it will be accepted for publication. Accepted manuscripts are then copyedited and typeset by the production team before online publication. Appeals against decisions following peer review are considered on a case-by-case basis and should be sent to the journal editor.
Preprints
We encourage posting of preprints of primary research manuscripts on preprint servers, authors’ or institutional websites, and open communications between researchers whether on community preprint servers or preprint commenting platforms. Posting of preprints is not considered prior publication and will not jeopardize consideration in our journals. Authors should disclose details of preprint posting during the submission process or at any other point during consideration in one of our journals. Once the manuscript is published, it is the author’s responsibility to ensure that the preprint record is updated with a publication reference, including the DOI and a URL link to the published version of the article on the journal website.
Please follow the link for further information on preprint sharing:
https://www.springer.com/gp/authors-editors/journal-author/journal-author-helpdesk/submission/1302#c16721550
Copyright
Ophthalmology and Therapy''s content is published open access under the Creative Commons Attribution-Noncommercial License, which allows users to read, copy, distribute, and make derivative works for non-commercial purposes from the material, as long as the author of the original work is cited. The author assigns the exclusive right to any commercial use of the article to Springer. For more information about the Creative Commons Attribution-Noncommercial License, click here: http://creativecommons.org/licenses/by-nc/4.0.
Contact
For more information about the journal, including pre-submission enquiries, please contact christopher.vautrinot@springer.com.
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