Methods
keratoconjunctivitis sicca
KERATOCONJUNCTIVITIS SICCA
We undertook a 24 week, randomized, multicenter, open-label, parallel group study in 155 adult patients with moderate to severe keratoconjunctivitis sicca to evaluate the efficacy and safety of a proprietary formulation of MNP Cyclosporine (0.05% w/v, New India Biopharma Pvt. Ltd.) applied to the ocular surface either once or twice a day as compared to RESTASIS™ (cyclosporine 0.05% w/v, Allergan India Pvt. Ltd.) applied to the ocular surface twice a day. An in vitro study using the Franz diffusion cells apparatus showed 3-fold higher retention in corneal tissue and significantly higher transcorneal release of CsA with MNP Cyclosporine than with RESTASIS™ (unpublished data on file), suggesting the possibility of superior clinical efficacy of MNP Cyclosporine over RESTASIS™. However, previous studies with RESTASIS™ had reported a lack of incremental dose response at concentrations above 0.05%