drugset / Trial / NCT01707381

BOL-303259-X With Timolol 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension

NCT01707381 ↗

Phase 2 Completed 25 enrolled Bausch & Lomb Incorporated
RandomizedCrossoverOpen-labelTreatment

Summary

This clinical investigation is being performed to compare the effect of BOL-303259-X dosed once daily (QD) with timolol maleate 0.5% dosed twice daily (BID) in reducing intraocular pressure (IOP) measured over a 24-hour period in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Timeline

Start
2012-11
Primary completion
2013-12
Completion
2014-02

Outcome

Met primary endpoint

registry analysis (other test); Timolol Maleate vs BOL-303259-X; p <0.001; Treatment difference -1.773 (95% CI -2.380 to -1.166); ANCOVA NCT01707381 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Latanoprostene bunod Small molecule 0.024 % Topical
Comparator Timolol Other / unclassified 0.5 % Topical