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Safety and Efficacy Study of CF101 to Treat Keratoconjunctivitis Sicca

2014-08-27 03:43:37 | BioPortfolio

Summary

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 moderate-to-severe KCS. Patients will be randomized to receive either CF101 1 mg or matching placebo, given orally q12h for 12 weeks. A Screening Period of up to 4 weeks that includes a 2-week run-in period will precede a 12-week treatment period, followed by a 2-week follow-up period.

Description

At a Screening Visit, patients who provide written informed consent will have screening procedures performed, including a complete medical history, medication history, physical examination, including height, weight, sitting blood pressure, pulse rate and temperature, and clinical laboratory tests. Disease activity will be assessed using tear meniscus height, tear break-up time, fluorescein staining, Schirmer test, and the Dry Eye Symptom Score. Doses of artificial tears must be stable for >2 weeks prior to the Screening Visit.

Eligible patients will begin a 2-week run-in period, during which time they will be instructed to discontinue use of all topical ophthalmic medications except for lubricant eye drops. Patients who successfully complete the 2-week run-in period will be randomized to their assigned medication (CF101 1 mg or matching placebo) to be taken orally q12h for 12 weeks. Patients will return for assessments and a new supply of study medication at Weeks 2, 4, 8 and 12, and at Week 14 for a final follow-up assessment.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Keratoconjunctivitis Sicca

Intervention

CF101, Placebo

Location

Meir Hospital
Kfar-Saba
Israel
44281

Status

Completed

Source

Can-Fite BioPharma

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:43:37-0400

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Medical and Biotech [MESH] Definitions

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Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

A species of gram-negative, aerobic BACTERIA found in the human NASOPHARYNX; SALIVA; and SPUTUM.

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