Restasis (Cyclosporine 0.05%)

Approved uses

Keratoconjunctivitis sicca with tear production presumed suppressed by ocular inflammation

One drop in each eye BID, approximately 12 hours apart

Effect is read at 6 months, with no added benefit from the higher 0.1% strength.

OFF-LABELNot in the FDA label for this product

Meibomian gland dysfunction (posterior blepharitis)

One drop BID for 3 months, the regimen used in both randomized trials

2 RCTs · n=103 · signs only

Perry 2006, randomized versus preservative-free artificial tears, 33 enrolled and 26 completed: at 3 months lid margin vascular injection, tarsal telangiectasis, fluorescein staining, and meibomian gland inclusions (P = 0.001) improved against control, while the symptom difference was not statistically significant and the authors concluded topical cyclosporine may be helpful but did not improve symptoms. Prabhasawat 2012, randomized double-masked versus 0.5% carboxymethylcellulose, 70 patients: tear breakup times were longer at every visit and the change from baseline greater at 3 months (P < 0.001), with the authors attributing the benefit mainly to tear film stability. Both are small single-center trials showing signs moving more than symptoms.

Perry HD, Doshi-Carnevale S, Donnenfeld ED, Solomon R, Biser SA, Bloom AH. Efficacy of commercially available topical cyclosporine A 0.05% in the treatment of meibomian gland dysfunction. Cornea. 2006;25(2):171-175. Second trial: Prabhasawat P, Tesavibul N, Mahawong W. A randomized double-masked study of 0.05% cyclosporine ophthalmic emulsion in the treatment of meibomian gland dysfunction. Cornea. 2012;31(12):1386-1393 (doi 10.1097/ICO.0b013e31823cc098).