CompletedPhase 3

Trial of CF101 to Treat Patients With Dry Eye Disease

Israel236 participantsStarted 2011-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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;

What they're measuring

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

Timeframe: 24 weeks

Number of Subjects With Adverse Events

Timeframe: 24 weeks

Trial details

NCT IDNCT01235234

SponsorCan-Fite BioPharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-11

Results submitted2015-02-22

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