Safety and Efficacy of Daily CF101 Administered Orally in Subjects With Elevated Intraocular Pressure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01033422|
Recruitment Status : Unknown
Verified December 2015 by Can-Fite BioPharma.
Recruitment status was: Recruiting
First Posted : December 16, 2009
Last Update Posted : December 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Ocular Hypertension Glaucoma||Drug: CF101 Drug: Placebo for||Phase 2|
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 44 subjects randomized in a 3:1 ratio to CF101 2.0 mg 3:1 ratio to receive with CF101 2.0 mg, or matching placebo, given orally every 12 hours for 16 weeks.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||April 2017|
CF101 (1 or 2 mg) orally q12 hours
CF101 1 or 2 mg tablets orally every 12 hours for 16 weeks
Other Name: IB-MECA
Placebo Comparator: Placebo
matching placebo orally q12 hours
Drug: Placebo for
Matching placebo tablets orally every 12 hours for 16 weeks
Other Name: Sugar pill
- Intraocular pressure [ Time Frame: 16 weeks ]
- Safety: Adverse event reporting, physical examination, vital signs, ophthalmologic and slit lamp examination, visual fields, clinical laboratory testing [ Time Frame: 16 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033422
|Contact: Sari Fishman, PhDfirstname.lastname@example.org|
|Contact: Zivit Harpazemail@example.com|
|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|