Clinical trial NCT01235234 (phase 3, status: completed)
Conditions: keratoconjunctivitis sicca
ICD codes: H16.223, H16.221, H16.222, H16.229
Drugs: cf101
SMILES: CNC(=O)[C@H]1O[C@H]([C@H](O)[C@@H]1O)N1C=NC2=C(NCC3=CC(I)=CC=C3)N=CN=C12
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.