Association of Oxymetazoline Hydrochloride, 0.1%, Solution Administration With Visual Field in Acquired Ptosis

医学 羟甲唑啉 上睑下垂 随机对照试验 安慰剂 视力 临床终点 麻醉 外科 眼科 内科学 肾上腺素能受体 病理 受体 替代医学
作者
Charles B. Slonim,Shane Foster,Mark Jaros,Shane Kannarr,Michael S Korenfeld,Robert Smyth-Medina,David Wirta
出处
期刊:JAMA Ophthalmology [American Medical Association]
卷期号:138 (11): 1168-1168 被引量:16
标识
DOI:10.1001/jamaophthalmol.2020.3812
摘要

Importance

Treatment of acquired blepharoptosis (ptosis) is currently limited to surgical intervention.

Objective

To examine the efficacy and safety of oxymetazoline hydrochloride, 0.1%, ophthalmic solution (oxymetazoline, 0.1%) in participants with acquired ptosis.

Design, Setting, and Participants

This pooled analysis of 2 randomized, double-masked, placebo-controlled, multicenter phase 3 clinical trials included participants 9 years and older with acquired ptosis and superior visual field deficit. The 2 studies were conducted across 16 and 27 sites in the United States. Patients were enrolled from May 2015 to April 2019. Analyses for the individual trials were initiated after database lock and completed on September 6, 2017, and May 16, 2019. Pooled analysis was completed on August 25, 2019.

Interventions

Participants (randomized 2:1) received oxymetazoline, 0.1%, or vehicle, self-administered as a single drop per eye, once daily, for 42 days.

Main Outcomes and Measures

The primary efficacy end point was change from baseline in the number of points seen on the Leicester Peripheral Field Test, a test to detect superior visual field deficits due to ptosis, on days 1 (6 hours after instillation) and 14 (2 hours after instillation). The secondary end point, change from baseline in marginal reflex distance 1, was assessed at the same time points.

Results

In total, 304 participants were enrolled (mean [SD] age, 63.8 [13.8] years; 222 women [73%]). Overall, 97.5% (198 of 203) of participants receiving oxymetazoline, 0.1%, and 97.0% (98 of 101) of participants receiving vehicle completed the studies. Oxymetazoline, 0.1%, was associated with a significant increase in the mean (SD) number of points seen on the Leicester Peripheral Field Test vs vehicle (day 1: 5.9 [6.4] vs 1.8 [4.1]; mean difference, 4.07 [95% CI, 2.74-5.39];P < .001; day 14: 7.1 [5.9] vs 2.4 [5.5]; mean difference, 4.74 [95% CI, 3.43-6.04];P < .001). Oxymetazoline, 0.1%, also was associated with a significant increase in marginal reflex distance 1 from baseline (mean [SD]: day 1: 0.96 [0.89] mm vs 0.50 [0.81] mm; mean difference, 0.47 mm [95% CI, 0.27-0.67];P < .001; day 14: 1.16 [0.87] mm vs 0.50 [0.80] mm; mean difference, 0.67 mm [95% CI, 0.46-0.88];P < .001). Treatment-emergent adverse events (TEAEs) occurred in 31.0% (63 of 203) of participants receiving oxymetazoline, 0.1%, and 35.6% (36 of 101) of participants receiving vehicle. Among participants receiving oxymetazoline, 0.1%, with a TEAE, 81% (51 of 63) had a maximum TEAE intensity of mild, and 62% (39 of 63) had no TEAE suspected of being treatment related.

Conclusions and Relevance

Oxymetazoline, 0.1%, was associated with positive outcomes and was well tolerated in phase 3 trials after instillation at days 1 and 14, demonstrating its potential promise for the treatment of acquired ptosis, although further study is needed to elucidate the clinical relevance of these findings beyond 6 weeks.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
刚刚
漫山发布了新的文献求助10
刚刚
summer发布了新的文献求助30
刚刚
dpp驳回了Lc应助
1秒前
Xiaoyang发布了新的文献求助10
1秒前
2秒前
lishen关注了科研通微信公众号
3秒前
4秒前
Rondab应助Luos采纳,获得10
6秒前
yx_cheng应助lilila666采纳,获得30
9秒前
11秒前
11秒前
12秒前
14秒前
Xiaoyang完成签到,获得积分10
14秒前
loski发布了新的文献求助10
14秒前
15秒前
虚心月饼发布了新的文献求助10
16秒前
17秒前
Lucas应助123采纳,获得10
19秒前
香蕉觅云应助KIORking采纳,获得10
20秒前
20秒前
Liufgui应助执着又蓝采纳,获得20
21秒前
21秒前
正直水池完成签到 ,获得积分10
21秒前
21秒前
阿克完成签到,获得积分10
21秒前
一方通行发布了新的文献求助10
22秒前
perovskite完成签到,获得积分10
22秒前
如梦如幻91完成签到,获得积分10
22秒前
22秒前
22秒前
妮露的修狗完成签到,获得积分10
23秒前
24秒前
25秒前
文献发布了新的文献求助30
27秒前
无花果应助我不吃胡萝卜采纳,获得10
28秒前
28秒前
29秒前
自信的电灯胆完成签到,获得积分20
29秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
ACSM’s Guidelines for Exercise Testing and Prescription, 12th edition 500
‘Unruly’ Children: Historical Fieldnotes and Learning Morality in a Taiwan Village (New Departures in Anthropology) 400
Indomethacinのヒトにおける経皮吸収 400
Phylogenetic study of the order Polydesmida (Myriapoda: Diplopoda) 370
基于可调谐半导体激光吸收光谱技术泄漏气体检测系统的研究 350
Robot-supported joining of reinforcement textiles with one-sided sewing heads 320
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3989378
求助须知:如何正确求助?哪些是违规求助? 3531442
关于积分的说明 11254002
捐赠科研通 3270126
什么是DOI,文献DOI怎么找? 1804887
邀请新用户注册赠送积分活动 882087
科研通“疑难数据库(出版商)”最低求助积分说明 809173