TY - JOUR
T1 - Treatment of dry eye syndrome with orally administered CF101
T2 - Data from a phase 2 clinical trial
AU - Avni, Isaac
AU - Garzozi, Hanna J.
AU - Barequet, Irina S.
AU - Segev, Fanni
AU - Varssano, David
AU - Sartani, Gil
AU - Chetrit, Noa
AU - Bakshi, Erez
AU - Zadok, David
AU - Tomkins, Oren
AU - Litvin, Gilad
AU - Jacobson, Kenneth A.
AU - Fishman, Sari
AU - Harpaz, Zivit
AU - Farbstein, Motti
AU - Yehuda, Sara Bar
AU - Silverman, Michael H.
AU - Kerns, William D.
AU - Bristol, David R.
AU - Cohn, Ilan
AU - Fishman, Pnina
PY - 2010/7
Y1 - 2010/7
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=77954348601&partnerID=8YFLogxK
U2 - 10.1016/j.ophtha.2009.11.029
DO - 10.1016/j.ophtha.2009.11.029
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C2 - 20304499
AN - SCOPUS:77954348601
SN - 0161-6420
VL - 117
SP - 1287
EP - 1293
JO - Ophthalmology
JF - Ophthalmology
IS - 7
ER -