Trial of CF101 to Treat Patients With Dry Eye Disease
Condition: Keratoconjunctivitis Sicca
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Keratoconjunctivitis
Intervention: CF101
Intervention description: orally q12h
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 236.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dry eye disease; KCS; Aqueous Deficient Dry Eye

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:

               1. 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

               2. FS score of ≥2 in at least one corneal region; AND

               3. Schirmer Test (ST) score (without anesthesia) ≥1 mm and < 7 mm/5 min in either
                  eye; AND

               4. 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.

        Exclusion Criteria:

          -  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;

          -  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.