Conditions: Keratoconjunctivitis Sicca
Keywords: Dry eye disease KCS Aqueous Deficient Dry Eye
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 236
Healthy volunteers: no

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.

Detailed description:
Patients will be randomized to receive either CF101 0.1 mg, CF101 1.0 mg, or matching placebo, given orally twice daily (BID) for 24 weeks. A Screening Period of up to 4 weeks that includes a 2-week run-in period will precede a 24-week treatment period, followed by a 2-week follow-up period.

At a Screening Visit, patients will undergo complete medical and ophthalmologic history, medication history, physical examination (including height, weight, sitting blood pressure, pulse rate and temperature), ophthalmic examination, and clinical laboratory tests. Disease activity will be assessed using fluorescein staining, Schirmer test with and without anesthesia, Ocular Surface Disease Index©, and tear break-up time.

Eligible patients will begin a 2-week run-in period during the 4-week screening period, during which time they will be instructed to discontinue use of all topical ophthalmic medications except for REFRESH TEARS® Lubricant Eye Drops. At the Baseline Visit, patients who successfully complete the 2-week run-in period and re-qualify for entry will be randomized to their assigned medication (CF101 0.1 mg, CF101 1.0 mg, or matching placebo) to be taken orally twice daily BID for 24 weeks. Patients will return for assessments and a new supply of study medication at Weeks 2, 4, 8, 12, 16, and 20; at Week 24 for a final on-treatment assessment; and at Week 26 for the 2-week off-treatment follow-up visit.

Arms:
arm 1: Subjects were randomized to receive CF 101 0.1mg, orally, twice daily for 24 weeks arm 2: Subjects were randomized to receive CF 101 1.0mg, orally, twice daily for 24 weeks arm 3: Subjects were randomized to receive matching placebo, orally, twice daily for 24 weeks

Interventions: intervention 1: CF101
Intervention descriptions: intervention 1: orally q12h

Protocol document: