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

Conditions: Open-Angle Glaucoma; Ocular Hypertension

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.


Eligibility criteria:
inclusion criteria: * participants must have a diagnosis of oag (including pigmentary or pseudoexfoliative) or oht in 1 or both eyes. * participants must meet the following iop requirements at visit 3 * mean/median iop ≥ 24 mmhg at a minimum of 2 time points in the same eye * iop ≤ 36 mmhg at all 3 measurement time points in both eyes. * participants with a best-corrected visual acuity (bcva), using the early treatment of diabetic retinopathy study (etdrs) protocol, of +0.7 logmar units (snellen equivalent of approximately 20/100) or better in either eye. exclusion criteria: * participants with known hypersensitivity or contraindications to latanoprost, no treatment, timolol maleate, other beta-adrenergic receptor antagonists or any of the ingredients in the study drugs. * participants with a central corneal thickness greater than 600 μm in either eye. * participants with advanced glaucoma and participants with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye. * participants who do not have an intact posterior capsule in either eye . * participants with aphakia in either eye. * participants with previous or active corneal disease in either eye. * participants with current or a history of severe dry eye in either eye. * participants with current or a history of optic disc hemorrhage in either eye. * participants with current or a history of central/branch retinal vein or artery occlusion in either eye. * participants with current or a history of macular edema in either eye. * participants with very narrow angles (3 quadrants with less than grade 2 according to shaffer's anterior chamber angle grading system) and participants with angle closure,congenital, and secondary glaucoma, and participants with history of angle closure in either eye. * participants with a diagnosis of a clinically significant or progressive retinal disease in either eye. * participants with any intraocular infection or inflammation in either eye within 3 months(90 days) prior to visit 1 (screening). * participants with a history of ocular laser surgery in either eye within the 3 months(90 days) prior to visit 1 (screening). * participants with a history of incisional ocular surgery or severe trauma in either eye within 3 months (90 days) prior to visit 1 (screening).

Keywords: intraocular pressure