Safety and Efficacy of Daily CF101 Administered Orally in Subjects With Elevated Intraocular Pressure
This study will test the hypothesis that CF101, administered orally, will reduce intraocular pressure in patients with ocular hypertension and/or glaucoma. Eligible patients with elevated intraocular pressure will be evaluated and treated by ophthalmologist investigators, and will receive either CF101 pills or placebo (dummy) pills twice daily for 16 weeks. Ocular pressure, visual fields, and other aspects of safety and effectiveness will be monitored on a regular basis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 2, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Daily CF101 Administered Orally in Subjects With Elevated Intraocular Pressure|
- Intraocular pressure [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Safety: Adverse event reporting, physical examination, vital signs, ophthalmologic and slit lamp examination, visual fields, clinical laboratory testing [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
CF101 1 mg orally q12 hours
CF101 1 mg tablets orally every 12 hours for 16 weeks
Other Name: IB-MECA
Placebo Comparator: Placebo
Placebo orally q12h
Matching placebo tablets orally every 12 hours for 16 weeks
Other Name: Sugar pill
This is a Phase 2, randomized, double-masked, placebo-controlled, parallel-group study in adult males and females, aged 18 years and over, with a diagnosis of glaucoma or ocular hypertension.
This trial will be performed in 2 segments. In Segment 1, subjects will be randomized to receive either CF101 1.0 mg, or matching placebo, given orally every 12 hours for 16 weeks. Segment 1 will enroll approximately 44 subjects, randomized in a 3:1 ratio to CF101 1.0 mg or to placebo. At the conclusion of Segment 1, a Data Review Committee (DRC) will review safety and efficacy data and advise on progression of the trial to Segment 2. Segment 2 will enroll up to approximately 88 subjects in up to 3 dose groups (CF101 0.1 mg, CF101 2.0 mg, or placebo every 12 hours) randomized in a 3:3:2 ratio. At its discretion, the DRC may also recommend increasing enrollment in the CF101 1.0 mg group or other changes to the protocol design.
At a Screening Visit (Visit 1, performed within 4 weeks prior to Baseline), subjects who provide written informed consent will have screening procedures performed, including complete medical, ophthalmologic, and medication histories; physical examination; vital signs and weight; electrocardiogram (ECG); ophthalmologic examination; tonometry; visual field (VF) assessment; corneal pachymetry; evaluation of inclusion and exclusion criteria; safety laboratory tests; serum pregnancy test for all females of child-bearing potential; and collection of concomitant medication information.
Subjects who successfully qualify will be randomized at Baseline (Visit 2) to their assigned medication (CF101 or matching placebo) to be taken orally every 12 hours for 16 weeks. Subjects will return for assessments and a new supply of study medication at Weeks 2, 4, 8, 12, and for final assessment and discharge at Week 16. A safety telephone call will be made at Week 18.
|Contact: Sari Fishman, PhDemail@example.com|
|Contact: Zivit Harpazfirstname.lastname@example.org|
|Specialized Hospital for Active Treatment for Eye Diseases "Zrenie"||Recruiting|
|Sofia, Bulgaria, 1408|
|Contact: Pravoslava Guguchkova-Ianchuleva, Prof.|
|Sub-Investigator: Bissera Samsonova, Dr.|
|University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL"||Recruiting|
|Sofia, Bulgaria, 1527|
|Contact: Ruska Hristova, Assoc. Prof.|
|Sub-Investigator: Hristina Hristova-Petrova, Dr.|
|Sub-Investigator: Irenna Demircheva, Dr.|
|Sub-Investigator: Reni Zaharieva|
|Bnei Zion Medical Center||Recruiting|
|Contact: Hana Garzuzi, MD|
|Study Director:||Michael H Silverman, MD||Can-Fite BioPharma|