To comparatively evaluate the efficacy of a bandage contact lens (BCL) and autologous serum (AS) eye drops in the management of severe dry eye caused by Sjögren syndrome (SS).
In this prospective randomized study, 40 patients with SS were enrolled. Patients were divided into 2 treatment groups: BCL and AS.
A total of 37 patients were included, 18 patients (35 eyes) in the AS group and 19 patients (36 eyes) in the BCL group. At the end of 6 weeks, the best-corrected visual acuity improved significantly in the BCL group (0.5 ± 0.3 vs. 0.3 ± 0.2, P = 0.003) but not in the AS group (0.4 ± 0.3 vs. 0.3 ± 0.3, P = 0.11). The best-corrected visual acuity remained stable up to 6 weeks after discontinuation of the BCL (0.5 ± 0.3 vs. 0.4 ± 0.2, P = 0.03). Although the Ocular Surface Disease Index scores decreased significantly after treatment in both groups, patients in the BCL group had lower Ocular Surface Disease Index scores than those in the AS group (53.4 vs. 41.8 at week 3, 47.1 vs. 31.0 at week 6, 52.7 vs. 32.0 at week 12; P = 0.014, <0.001, <0.004, respectively). The "faces" scores showed improved quality of life in both groups. Tear break-up time improved significantly in both groups except at 6 weeks after discontinuation of the AS. Patients in the BCL group had lower corneal staining scores than those of the AS group after 6 weeks of treatment and 6 weeks after discontinuation of treatment (P < 0.01). There was no significant change in Schirmer I test scores between or within groups.
Balafilcon A silicone hydrogel contact lenses as a BCL were effective in the management of SS-associated dry eye. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT02147509.