Phase 3
N=236
Trial of CF101 to Treat Patients With Dry Eye Disease
Keratoconjunctivitis Sicca
Bottom Line
View on ClinicalTrials.gov: NCT01235234 ↗Enrolled (actual)
236
Serious AEs
3.0%
Results posted
Mar 2015
Primary outcome: Primary: Number of Subjects Who Achieved Complete Clearing of Corneal Staining (i.e., Total Corneal FS Score = 0) at Week 24 — 15; 13; 21; 61 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CF101 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Can-Fite BioPharma
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Achieved Complete Clearing of Corneal Staining (i.e., Total Corneal FS Score = 0) at Week 24 |
15; 13; 21; 61; 64; 55 | — |
| PRIMARY Number of Subjects With Adverse Events |
29; 37; 29; 1; 0; 3 | — |
| SECONDARY Number of Subjects Who Achieve an Increase in Schirmer Test Tearing by >9mm Over Baseline |
15; 13; 13; 61; 64; 63 | — |
| SECONDARY Ocular Surface Disease Index |
-24.27; -25.63; -28.70 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 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;
- Meibomian gland dysfunction (MGD) of greater than mild degree, defined as mild plugging of the Meibomian glands without lid margin inflammation;
- Surgical occlusion of the lacrimal puncta, including the insertion of punctual plugs, within 3 months of the Screening Visit.
Data sourced from ClinicalTrials.gov (NCT01235234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.