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

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• 作者：Isaac Avni ; Hanna J. Garzozi ; Irina S. Barequet ; Fanni Segev ; David Varssano ; Gil Sartani ; Noa Chetrit ; Erez Bakshi ; David Zadok ; Oren Tomkins ; Gilad Litvin ; Kenneth A. Jacobson ; Sari Fishman ; Zivit H
• 刊名：Ophthalmology
• 出版年：2010
• 出版时间：July 2010
• 年：2010
• 卷：117
• 期：7
• 页码：1287-1293
• 全文大小：443 K

文摘

Objective

To explore the safety and efficacy of CF101, an A₃ 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.