Safety and Efficacy of Hydroxypropyl Guar-Hyaluronic Acid Dual-Polymer Lubricating Eye Drops in Indian Subjects with Dry Eye: A Phase IV Study.

IF 2.6 3区医学 Q2 OPHTHALMOLOGY

Ophthalmology and Therapy Pub Date : 2024-12-14 DOI:10.1007/s40123-024-01069-9

Deborah Awisi-Gyau, Neha Kapur, Rajesh Parekh, Umesh Yeddula, Shreesha Kumar Kodavoor

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Abstract

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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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。

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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. 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