Efficacy and Safety of SJP-0132 in Patients With Dry Eye Disease: A Phase 2b Randomized, Double-Masked, Dose-Finding Study

IF 4.7 1区医学 Q1 OPHTHALMOLOGY

American Journal of Ophthalmology Pub Date : 2026-03-01 Epub Date: 2025-12-04 DOI:10.1016/j.ajo.2025.11.036

Yuichi Hori , Tomoyuki Wada , Kazunori Omatsu

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引用次数: 0

Abstract

Objective

Evaluate the efficacy, safety, and optimal dose of the TRPV1 antagonist SJP-0132 ophthalmic suspension in patients with dry eye disease.

Design

Randomized, double-masked, multicenter, placebo-controlled, Phase 2b dose-response study in Japan.

Participants

Outpatients aged ≥20 years with dry eye-related subjective symptoms (eye dryness visual analog scale score ≥40; 5-item Dry Eye Questionnaire score ≥6), and objective signs (mean tear-breakup time ≤5 seconds in both eyes; corneal fluorescein staining [CFS] score using Baylor criteria: 2 to 4 for central zone of at least one eye, total score 4 to 20 for all zones, and ≥1 for at least one of the four peripheral corneal regions).

Methods

After a 2-week placebo run-in period, patients were randomized 1:1:1:1 to receive SJP-0132 ophthalmic suspension 0.1%, 0.3%, or 1.0%, or placebo, administered as 1 drop in each eye four times daily for 4 weeks.

Main Outcome Measures

The primary endpoint was the change from baseline to week 4 in CFS score for all zones with SJP-0132 0.3% vs placebo (primary analysis) and SJP-0132 0.1% or 1.0% vs placebo (secondary analysis).

Results

Total 344 patients were randomized and received at least one dose of SJP-0132 0.1% (n = 87), SJP-0132 0.3% (n = 87), SJP-0132 1.0% (n = 85), or placebo (n = 85). For the primary endpoint, there were no statistically significant differences between the SJP-0132 0.3% and placebo groups (between-group difference −0.8; 95% CI −1.7, 0.2; P = .1181), or between the SJP-0132 0.1% (−0.7; 95% CI −1.8, 0.4; P = .1990) or SJP-0132 1.0% (−0.1; 95% CI −1.3, 1.0; P = .8276) and placebo groups. Secondary endpoints showed generally dose-dependent efficacy and safety of SJP-0132. Improvements in subjective symptoms of dry eye, quality of life, and objective signs were observed after 1 week of SJP-0132 administration and maintained through to week 4, with statistically significant differences to placebo observed at some endpoints. Subgroup analyses suggested greater treatment benefits with SJP-0132 0.3% in subgroups based on baseline ocular characteristics. SJP-0132 was generally well tolerated across the dose groups.

Conclusions

SJP-0132 showed generally dose-dependent efficacy and safety. Based on safety and treatment benefits with SJP-0132 0.3% in the overall population and in subgroups, this dose was considered optimal for further development.

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SJP-0132治疗干眼病的疗效和安全性：一项2b期随机、双盲、剂量发现研究

目的评价TRPV1拮抗剂SJP-0132眼液在干眼病患者中的疗效、安全性和最佳剂量。日本随机、双盲、多中心、安慰剂对照、2b期剂量反应研究。参与者年龄≥20岁，伴有干眼相关主观症状（眼睛干燥视觉模拟量表评分≥40分；干眼问卷5项评分≥6分）和客观体征（双眼平均泪液破裂时间≤5秒；采用贝勒标准的角膜荧光素染色[CFS]评分：至少一只眼睛中心区评分为2-4分，所有区域评分为4-20分，四个角膜周围区域中至少一个评分≥1分）的门诊患者。方法：在2周安慰剂磨合期后，患者按1:1:1:1:1随机接受SJP-0132眼液0.1%、0.3%或1.0%，或安慰剂，每天4次，每只眼滴1滴，持续4周。主要结局指标主要终点是所有区域从基线到第4周的CFS评分变化，其中SJP-0132与安慰剂相比为0.3%（主要分析），SJP-0132与安慰剂相比为0.1%或1.0%（次要分析）。结果344例患者随机接受至少一剂SJP-0132 0.1% （n=87）、SJP-0132 0.3% （n=87）、SJP-0132 1.0% （n=85）或安慰剂（n=85）治疗。对于主要终点，SJP-0132 0.3%组与安慰剂组之间无统计学差异（组间差异-0.8;95% CI -1.7, 0.2; p=0.1181）， SJP-0132 0.1%组（-0.7;95% CI -1.8, 0.4; p=0.1990）或SJP-0132 1.0%组（-0.1;95% CI -1.3, 1.0; p=0.8276）与安慰剂组之间无统计学差异。次要终点显示SJP-0132的有效性和安全性普遍呈剂量依赖性。SJP-0132给药1周后，观察到干眼的主观症状、生活质量和客观体征的改善，并维持到第4周，在某些终点与安慰剂观察到的差异有统计学意义。亚组分析显示，基于基线眼部特征的亚组中，SJP-0132 0.3%的治疗效果更好。SJP-0132在各剂量组均具有良好的耐受性。结论ssjp -0132具有一定的剂量依赖性。基于SJP-0132在总体人群和亚组中的安全性和治疗益处，该剂量被认为是进一步开发的最佳剂量。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

American Journal of Ophthalmology 医学-眼科学

CiteScore

9.20

自引率

7.10%

发文量

406

审稿时长

36 days

期刊介绍： The American Journal of Ophthalmology is a peer-reviewed, scientific publication that welcomes the submission of original, previously unpublished manuscripts directed to ophthalmologists and visual science specialists describing clinical investigations, clinical observations, and clinically relevant laboratory investigations. Published monthly since 1884, the full text of the American Journal of Ophthalmology and supplementary material are also presented online at www.AJO.com and on ScienceDirect. The American Journal of Ophthalmology publishes Full-Length Articles, Perspectives, Editorials, Correspondences, Books Reports and Announcements. Brief Reports and Case Reports are no longer published. We recommend submitting Brief Reports and Case Reports to our companion publication, the American Journal of Ophthalmology Case Reports. Manuscripts are accepted with the understanding that they have not been and will not be published elsewhere substantially in any format, and that there are no ethical problems with the content or data collection. Authors may be requested to produce the data upon which the manuscript is based and to answer expeditiously any questions about the manuscript or its authors.