Study Comparing the Safety and Efficacy of BOL-303259-X to Latanoprost in Subjects With Glaucoma or Ocular Hypertension

Phase 2 Completed 413 enrolled Bausch & Lomb Incorporated

RandomizedParallel-groupSingle-blindScreening

Summary

The objective of this clinical investigation is to determine the most effective drug concentration(s) of BOL-303259-X in the reduction of IOP in order to support further clinical development of an appropriate dose with regard to efficacy, and ocular and systemic safety.

Timeline

Start: 2010-12-13
Primary completion: 2011-12-20
Completion: 2012-06-22

Publications

Results Weinreb RN, Ong T, Scassellati Sforzolini B, Vittitow JL, Singh K, Kaufman PL; VOYAGER study group. A randomised, controlled comparison of latanoprostene bunod and latanoprost 0.005% in the treatment of ocular hypertension and open angle glaucoma: the VOYAGER study. Br J Ophthalmol. 2015 Jun;99(6):738-45. doi: 10.1136/bjophthalmol-2014-305908. Epub 2014 Dec 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Latanoprost	Small molecule	0.005 %	Topical
Subject	Latanoprostene bunod	Small molecule	0.006 %	Topical
Subject	Latanoprostene bunod	Small molecule	0.012 %	Topical
Subject	Latanoprostene bunod	Small molecule	0.024 %	Topical
Subject	Latanoprostene bunod	Small molecule	0.04 %	Topical

Indications

No indication recorded.