Multicenter, Randomized, Controlled Study of the Effect of Lotemax on Initiation of Dry Eye Treatment With Restasis

Phase 4 Completed 5 enrolled Ophthalmic Consultants of Long Island Bausch & Lomb Incorporated · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

To evaluate the impact of Lotemax on the initiation of Restasis therapy in patients with dry eye. It is hypothesized that the anti-inflammatory activity of Lotemax may help mitigate the stinging with cyclosporine administration and the dry eye signs and symptoms experienced during the initiation of therapy.

Timeline

Start: 2006-11
Primary completion: 2007-09
Completion: 2007-09

Outcome

Met primary endpoint

paper Loteprednol etabonate showed significantly more OSDI improvement than AT. PMID 25083776 ↗

paper Loteprednol etabonate showed superior improvement in Schirmer test, fluorescein staining, and lissamine staining. PMID 25083776 ↗

Publications

Sheppard JD, Donnenfeld ED, Holland EJ, Slonim CB, Solomon R, Solomon KD, McDonald MB, Perry HD, Lane SS, Pflugfelder SC, Samudre SS. Effect of loteprednol etabonate 0.5% on initiation of dry eye treatment with topical cyclosporine 0.05%. Eye Contact Lens. 2014 Sep;40(5):289-96. doi: 10.1097/ICL.0000000000000049.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Loteprednol Etabonate	Other / unclassified	0.5 %	—
Background	Cyclosporine	Peptide	0.05 %	Topical