To determine efficacy and safety of Carbopol 974P in the treatment of severe to moderate keratoconjunctivitis sicca (KCS) in patients with primary Sjögren's syndrome (SS) not responding to standard treatment with artificial tears.
60 patients (57 F, 3 M, mean age 52.5+/-12.0, mean disease duration 12.2+/-7.1 yrs) affected with primary SS diagnosed according to the European Community Study Group criteria were studied. Foregoing medications for SS and artificial tears for KCS have not been changed within 3 and 2 months respectively prior to the study onset. In all cases Carbopol 974P was added because symptoms of KCS were not adequately controlled with traditional lubricants. Schirmer I test, B.U.T. (break up time), rose Bengal-stain, clinical ophthalmological examination (i.e. fluorescein staining, keratis, corneal infiltrates and ulcers) and a questionnaire for dry eye symptoms (range 0-30) were performed at entry (T0) and after 2 (T1) and 12 (T2) weeks. Assessment of global efficacy was obtained by VAS 0-100 at T2 either by patients and by the ophthalmologist.
Lachrymal tests significantly improved after 2 and, even more, after 12 weeks. Clinical ophthalmologic picture also ameliorated: a remarkable reduction of fluorescein positive lesions was demonstrated from 71.6% of the cases at T0 to 38.3% at T2. Total score of symptoms (T0: 16.1+/-7.3) dropped to 11.9+/-6.6 (T1) (p=0.000) and then to 6.7+/-5.3 (T2) (p=0.000). Global efficacy expressed by patients and physician was 74.8+/-15.9 and 76.6+/-13.0, respectively. No adverse events (blurred vision, allergy) were reported throughout the study.
Our study seems to demonstrate that addition of Carbopol 974P to the traditional therapeutic armamentarium for moderate to severe KCS is useful and well accepted in patients with primary SS in which management of ocular symptoms is unsatisfactory.