Trial of CF101 to Treat Patients With Dry Eye Disease

NCT01235234 | Completed Phase 3 Results

• 1 other identifier: CF101-301KCS
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

Eligible patients with dry eye will be treated with CF101 or placebo twice daily for 24 weeks. Disease activity will be assessed using evaluations of ocular surface integrity, tear production, and patient symptoms.

Conditions

Keratoconjunctivitis Sicca

Keywords

Dry eye disease; KCS; Aqueous Deficient Dry Eye

Outcome Measures

Primary Outcomes (2)

• Number of Subjects Who Achieved Complete Clearing of Corneal Staining (i.e., Total Corneal FS Score = 0) at Week 24

  Complete clearing of corneal staining by fluorescein staining (FS). The primary efficacy analysis was performed for 1eye (target eye), defined as the eye with the larger corneal FS value at Baseline. If both eyes had the same corneal FS value at baseline, the target eye was considered the eye with the larger central corneal staining value at Baseline. Corneal FS defined as a corneal punctate fluorescein staining score of ≥4 in either eye by the National Eye Institute evaluation scale summed over 5 areas each with a 0-3 scoring scale

  24 weeks

• Number of Subjects With Adverse Events

  Determine the safety of oral CF 101 in this subject population. Adverse Events (AEs) and changes in vital signs, physical examination, clinical laboratory tests (liver, kidney, hematology, chemistry and urinalysis), electrocardiogram (ECG) findings, slit lamp and ophthalmic examination, visual acuity, and intraocular pressure measurements.

  24 weeks

Secondary Outcomes (2)

• Number of Subjects Who Achieve an Increase in Schirmer Test Tearing by >9mm Over Baseline

  24 weeks

• Ocular Surface Disease Index

  24 weeks

Study Arms (3)

CF101 0.1 mg

EXPERIMENTAL

Subjects were randomized to receive CF 101 0.1mg, orally, twice daily for 24 weeks

Drug: CF101

CF101 1 mg

EXPERIMENTAL

Subjects were randomized to receive CF 101 1.0mg, orally, twice daily for 24 weeks

Drug: CF101

Placebo

PLACEBO COMPARATOR

Subjects were randomized to receive matching placebo, orally, twice daily for 24 weeks

Drug: CF101

Interventions

CF101 DRUG

orally q12h

Also known as: IB-MECA

CF101 0.1 mg; CF101 1 mg; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years of age and over;
• Have a diagnosis of moderate-to-severe Aqueous-Deficient Dry Eye (including Sjögren's Syndrome dry eye), as defined by:
• Positive corneal fluorescein staining (FS), defined as a corneal punctate fluorescein staining score of ≥4 in either eye by the National Eye Institute evaluation scale summed over 5 areas each with a 0-3 scoring scale; AND
• FS score of ≥2 in at least one corneal region; AND
• Schirmer Test (ST) score (without anesthesia) ≥1 mm and \< 7 mm/5 min in either eye; AND
• OSDI score of ≥20;
• Central corneal FS score of ≥2 in at least 1 eye;
• Willing to use no topical ocular treatments, other than REFRESH® unpreserved artificial tears up to a maximum of 4 times daily, for the duration of the trial (including the 2-week run-in period, the 24-week treatment period and the 2-week follow-up period);
• Willing to forego periocular cosmetic application for the duration of the trial;
• Females of child-bearing potential must have a negative urine pregnancy test at screening and throughout the study, to be eligible for, and continue participation in, the study;
• Females of child-bearing potential must be willing to use 2 methods of contraception deemed adequate by the Investigator (for example oral contraceptive pills plus a barrier method) to be eligible for, and continue participation in, the study;
• Ability to complete the study in compliance with the protocol; and
• Ability to understand and provide written informed consent.

You may not qualify if:

• Sjögren's Syndrome with significant systemic non-exocrine gland involvement which, in the investigator"s opinion, would interfere with the conduct of the trial;
• Stevens-Johnson Syndrome;
• Use of methotrexate or systemic cyclosporine within the 3 months prior to the Screening Visit;
• of any other disease-modifying anti-rheumatic therapy within 2 months prior to the Screening Visit;
• Use of any anti-rheumatic biological agent within 2 months, or 5 half-lives, whichever is longer, prior to the Screening Visit;
• Use of oral corticosteroids \>10 mg prednisone, or equivalent, per day;
• Use of topical steroids within 4 weeks prior to the Screening Visit and for the duration of the study;
• Receipt of topical cyclosporine eye drops within 3 months prior to the Screening Visit and for the duration of the trial;
• Use of oral statin or preparation containing omega-3 fatty acid unless dose has been stable for at least 3 months and will remain so during the course of the trial;
• Presence of chronic ocular disease other than Aqueous-Deficient Dry Eye requiring topical treatment;
• Presence of post-burn ocular injury;
• Ocular herpes simplex virus infection;
• Concomitant use of contact lenses or use within 3 months prior to the Screening Visit;
• Persistent intraocular inflammation or infection;
• Active anterior blepharitis of greater than mild degree, defined as minimal crust at the base of the eyelashes and no signs of inflammation;

Sponsors & Collaborators

• Can-Fite BioPharma: lead

Study Sites (1)

Bnei Zion Medical Center

Haifa, 31048, Israel

Location

Related Publications (1)

• Avni I, Garzozi HJ, Barequet IS, Segev F, Varssano D, Sartani G, Chetrit N, Bakshi E, Zadok D, Tomkins O, Litvin G, Jacobson KA, Fishman S, Harpaz Z, Farbstein M, Yehuda SB, Silverman MH, Kerns WD, Bristol DR, Cohn I, Fishman P. Treatment of dry eye syndrome with orally administered CF101: data from a phase 2 clinical trial. Ophthalmology. 2010 Jul;117(7):1287-93. doi: 10.1016/j.ophtha.2009.11.029. Epub 2010 Mar 20.

  PMID: 20304499 BACKGROUND

Related Links

• Sponsor

MeSH Terms

Conditions

Keratoconjunctivitis Sicca; Dry Eye Syndromes

Interventions

CF101; N(6)-(3-iodobenzyl)-5'-N-methylcarboxamidoadenosine

Condition Hierarchy (Ancestors)

Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases

Results Point of Contact

• Title: Pnina Fishman, PhD
• Organization: Can-Fite Biopharma

pnina@canfite.co.il

011972 39241114

Study Officials

• Michael H Silverman, MD

  Can-Fite BioPharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: November 5, 2010
• Study Start: July 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 30, 2022
• Results First Posted: March 11, 2015

Record last verified: 2022-06

Locations

IL (1)