Assaf Harofe Medical Center, Zeriffin, Beer Yaakov, Israel.
Ophthalmology. 2010 Jul;117(7):1287-93. doi: 10.1016/j.ophtha.2009.11.029. Epub 2010 Mar 20.
To explore the safety and efficacy of CF101, an A(3) adenosine receptor agonist, in patients with moderate to severe dry eye syndrome.
Phase 2, multicenter, randomized, double-masked, placebo-controlled, parallel-group study.
Sixty-eight patients completed the study, 35 patients in the placebo group and 33 patients in the CF101 group.
Patients were treated orally with either 1 mg CF101 pills or matching vehicle-filled placebo pills, given twice daily for 12 weeks, followed by a 2-week posttreatment observation.
An improvement of more than 25% over baseline at week 12 in one of the following parameters: (1) tear break-up time (BUT); (2) superficial punctate keratitis assessed by fluorescein staining results; and (3) Schirmer tear test 1 results. Clinical laboratory safety tests, ophthalmic examinations, intraocular pressure (IOP) measurements, electrocardiographic evaluations, vital sign measurements, and monitoring of adverse events.
A statistically significant increase in the proportion of patients who achieved more than 25% improvement in the corneal staining and in the clearance of corneal staining was noted between the CF101-treated group and the placebo group. Treatment with CF101 resulted in a statistically significant improvement in the mean change from baseline at week 12 of the corneal staining, BUT, and tear meniscus (TM) height in the CF101-treated group. CF101 was well tolerated and exhibited an excellent safety profile with no serious adverse events. A statistically significant decrease from baseline was observed in the IOP of the CF101-treated group in comparison with the placebo group.
CF101, given orally, induced a statistically significant improvement in the corneal staining and an improvement in the BUT and TM in patients with moderate to severe dry eye syndrome. The drug was very well tolerated. These data and the anti-inflammatory characteristic of CF101 support further study of the drug as a potential treatment for the signs and symptoms of dry eye syndrome.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
探讨 CF101（一种 A（3）腺苷受体激动剂）在中重度干眼症患者中的安全性和疗效。
2 期、多中心、随机、双盲、安慰剂对照、平行组研究。
68 名患者完成了研究，安慰剂组 35 名，CF101 组 33 名。
患者每日口服 1mg CF101 片或匹配的安慰剂片，每日 2 次，持续 12 周，然后进行 2 周的治疗后观察。
在第 12 周时，以下参数之一的改善超过基线值的 25%：（1）泪膜破裂时间（BUT）；（2）荧光素染色结果评估的浅层点状角膜病变；和（3）Schirmer 泪液测试 1 结果。临床实验室安全性测试、眼科检查、眼压（IOP）测量、心电图评估、生命体征测量和不良事件监测。
CF101 治疗组与安慰剂组相比，角膜染色和角膜染色清除率超过 25%改善的患者比例有统计学显著增加。CF101 治疗可显著改善第 12 周时角膜染色、BUT 和泪膜高度的平均变化。CF101 耐受性良好，具有极好的安全性，无严重不良事件。与安慰剂组相比，CF101 治疗组的 IOP 从基线显著下降。
CF101 口服给药可显著改善中重度干眼症患者的角膜染色，并改善 BUT 和 TM。该药物耐受性良好。这些数据和 CF101 的抗炎特性支持进一步研究该药物作为干眼症综合征体征和症状的潜在治疗方法。
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