Treatment of Dry Eye Syndrome with Orally Administered CF101 Data from a Phase 2 Clinical Trial

被引：65

作者：

Avni, Isaac ^{[2
]}

Garzozi, Hanna J. ^{[3
]}

Barequet, Irina S. ^{[4
]}

Segev, Fanni ^{[5
]}

Varssano, David ^{[6
]}

Sartani, Gil ^{[7
]}

Chetrit, Noa ^{[2
]}

Bakshi, Erez ^{[2
]}

Zadok, David ^{[2
]}

Tomkins, Oren ^{[3
]}

Litvin, Gilad ^{[5
]}

Jacobson, Kenneth A. ^{[8
]}

Fishman, Sari ^{[1
]}

Harpaz, Zivit ^{[1
]}

Farbstein, Motti ^{[1
]}

Bar Yehuda, Sara ^{[1
]}

Silverman, Michael H. ^{[1
]}

Kerns, William D. ^{[1
]}

Bristol, David R. ^{[1
]}

Cohn, Ilan ^{[1
]}

Fishman, Pnina ^{[1
]}

机构：

[1] Can Fite BioPharma Ltd, IL-49170 Petah Tiqwa, Israel

[2] Assaf Harofe Med Ctr, Beer Yaagov, Israel

[3] Bnei Zion Med Ctr, Haifa, Israel

[4] Tel Aviv Univ, Sackler Fac Med, Goldschleger Eye Inst, Chaim Sheba Med Ctr, IL-52621 Tel Hashomer, Israel

[5] Meir Med Ctr, Kefar Sava, Israel

[6] Tel Aviv Univ, Tel Aviv Sourasky Med Ctr, IL-69978 Tel Aviv, Israel

[7] Haemek Med Ctr, Afula, Israel

[8] NIDDK, NIH, Bethesda, MD USA

来源：

OPHTHALMOLOGY | 2010年 / 117卷 / 07期

基金：

美国国家卫生研究院;

关键词：

A(3) ADENOSINE RECEPTOR; OCULAR SURFACE; IB-MECA; AGONISTS; EXPRESSION; ARTHRITIS; EFFICACY; CHANNELS; THERAPY; SAFETY;

D O I：

10.1016/j.ophtha.2009.11.029

中图分类号：

R77 [眼科学];

学科分类号：

100212 ;

摘要：

Objective: To explore the safety and efficacy of CF101, an A(3) adenosine receptor agonist, in patients with moderate to severe dry eye syndrome. Design: Phase 2, multicenter, randomized, double-masked, placebo-controlled, parallel-group study. Participants: Sixty-eight patients completed the study, 35 patients in the placebo group and 33 patients in the CF101 group. Intervention: 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. Main Outcome Measures: 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. Results: 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. Conclusions: 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. Ophthalmology 2010; 117: 1287-1293 (C) 2010 by the American Academy of Ophthalmology.

引用

页码：1287 / 1293

页数：7

共 34 条

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