【奥译言】可以减少眼睛瘙痒的隐形眼镜可能成为现实

2019-04-04 09:18  阅读数:617 标签:

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一份最新报告称,两项临床后期研究的结果表明,一款试验性隐形眼镜不仅能改善视力,还能防止因过敏引起的瘙痒。


研究人员在Cornea杂志上报告称,强生公司(Johnson & Johnson)研发并测试的这种含抗组胺的隐形眼镜能显著缓解眼部过敏症状。


“这些结果非常令人鼓舞,而超过20%的人存在眼睛过敏问题,这极大地影响着他们的生活质量。”强生公司视力保健公司(Johnson & Johnson Vision Care)临床科学主任Brian Pall说。


在两项由强生公司资助的随机临床试验中,测试了可以缓慢释放抗组胺酮替芬的隐形眼镜的有效性和安全性。这两项试验共入组了244名受试者, 年龄从12岁到61岁不等。


受试者要么佩戴两个用抗组胺药处理过的隐形眼镜,要么佩戴两个不含抗组胺药的普通隐形眼镜,抑或是每种隐形眼镜各佩戴一个,但他们不知道自己戴的是什么隐形眼镜。


受试者戴上隐形眼镜后,他们会接触通常会引起眼睛发痒的过敏原。戴上隐形眼镜15分钟和12小时后,研究人员分别要求他们按照0~4分五个等级对自己眼睛的发痒程度进行评分。那些佩戴含抗组胺药隐形眼镜的受试者的平均得分要低1分以上,分值从0到4分不等。


研究人员报告称,在这两项研究中,出现了24起不良事件,不过大多数都是轻微不良事件。一名受试者的双眼出现了两起严重不良事件,研究人员称之为“过度流泪”。


Pall说,一些佩戴含药隐形眼镜的受试者没有出现瘙痒症状,而另一些受试者则出现了烦人但尚可忍受的瘙痒症状。


Pall对这一新型隐形眼镜满怀激情与信念。“我们非常兴奋有机会发表这项技术,”他说。


纽约长老会医院( NewYork-Presbyterian)和威尔康奈尔医学院(Weill Cornell Medicine)的眼科医师兼教授Christopher Starr博士也对这一新研究成果表示欢迎。


“这在许多方面都非常新颖有趣,” Starr说,“我在纽约治疗过很多季节性过敏患者。马上他们将面临四月至五月期间到来的第一个季节性过敏高峰期。”


当下,Starr建议那些季节性过敏患者在佩戴隐形眼镜前10分钟往眼睛里滴入抗组胺药。“然后他们可以全天保持佩戴,”他说。“摘下隐形眼睛后,他们需要再往眼睛里滴入抗组胺药。”


Starr说:“事实上,我自己的眼睛有时也会发痒,因为有这些积极的数据,这个产品我自己也会用。”


Starr接着又表示,令人放心的是,这款新产品是两种产品的组合,而这两种产品的安全记录都得到了证实。


Pall说,他不确定这款新型隐形眼镜何时会出现在商店货架上供人购买。


“不言而喻,我们正在努力为获得监管部门的上市批准做准备。”“根据我的经验,开始与监管部门会面并展开讨论时,很难预测事情会如何发展。但这些具有说服力的临床数据无不令人鼓舞,我们坚信这些数据将为后续的上市批准申请提供强有力的支持。" Pall说。


英文原文


Contact lenses that reduce eye itch may become a reality


Experimental contact lenses that not only improve vision, but also ward off itchiness due to allergies, got a boost with the completion of two late-stage studies, according to a new report.


The antihistamine-containing lenses, developed and tested by Johnson & Johnson, significantly quieted eye allergy symptoms, researchers reported in Cornea.


"These are pretty encouraging results," said coauthor Brian Pall, director of clinical science for Johnson & Johnson Vision Care. "Over 20 percent of people suffer from eye allergies. It has a pretty big impact on their quality of life."


The two randomized trials - both funded by Johnson & Johnson - tested the effectiveness and safety of lenses that slowly release the antihistamine ketotifen. Together the trials included 244 volunteers whose ages ranged from 12 to 61.


Participants either wore two antihistamine-treated lenses, two regular lenses without the antihistamine, or one of each - but they didn't know what they were wearing.


After volunteers put the lenses in, they were exposed to allergens that would normally make their eyes itch. They were asked to rate on a scale of zero to four how itchy their eyes were at 15 minutes after the lenses were inserted and 12 hours after insertion. Scores were lower on average, by more than one point on a scale of zero to four, when volunteers had medicated lenses in.


Between the two studies there were 24 adverse events, most of which were mild, the researchers reported. There were two more-severe adverse events that occurred in both eyes of one volunteer, which the researchers described as "excess tearing."


Some of the volunteers who wore lenses with antihistamine reported no itching, while others reported itching that was bothersome, but tolerable, Pall said.


Pall is very enthusiastic about the new lenses. "We are super excited to have this opportunity to publish on this technology," he said.


Dr. Christopher Starr welcomed the new findings.


"This is really novel and interesting on a number of levels," said Starr, an ophthalmologist and professor at NewYork-Presbyterian and Weill Cornell Medicine. "I do treat a lot of patients with seasonal allergies in New York City. Right now they're bracing for the first peak that comes from April to May."


Currently Starr advises those patients to put antihistamine drops in their eyes 10 minutes before they put their lenses in. "Then they can wear them throughout the day," he said. "And then they put a second drop in their eyes after they take the lenses out."


In fact, Starr said, "my own eyes itch and this is a product that on first glance - with this positive data - is something I would use myself."


It's also reassuring that the new product is a combination of two items that have proven track records for safety, Starr said.


Pall says he doesn't know when the new lenses might show up on store shelves.


"Obviously we are committed to getting all the pieces in place for regulatory submission," he said. "In my experience it's very hard to predict how things will go when you start to meet and discuss with regulatory bodies. But we are encouraged by this robust clinical data that would support a submission (for approval) in the future."




来源:Reuters

原文链接:https://www.reuters.com/article/us-health-eyes-allergies/contact-lenses-that-reduce-eye-itch-may-become-a-reality-idUSKCN1RB001?feedType=RSS&feedName=healthNews

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