NCT01749930

Comparing the Safety and Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension

A Randomized, Multicenter, Double-Masked, Parallel-Group Study Comparing the Safety and Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In participants with a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT), the primary objective is to demonstrate that the mean IOP reduction after 3 months of treatment with BOL-303259-X once daily (QD) is non-inferior to timolol maleate 0.5% twice daily (BID). The secondary objective is to demonstrate the superiority of BOL-303259-X QD to timolol maleate 0.5% BID. This assessment will be performed if the non-inferiority of BOL-303259-X QD to timolol maleate 0.5% BID is determined. An open label safety phase will be conducted at the end of Visit 6 (3 months) where all participants will receive BOL-303259-X QD for an additional 3 months.

Conditions

• Open-Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	BOL-303259-X	BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning
DRUG	Timolol	Timolol will be administered BID once in the morning and once in the evening.
DRUG	BOL-303259-X	All participants will receive a topical ocular BOL-303259-X QD in the evening from 3 months (Visit 6) through 6 months (Visit7).

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2012-12-17
• Last updated: 2018-11-21
• Results posted: 2018-11-21

Locations

1 site across 1 country: United States