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

A Randomized, Multicenter, Single-Masked, Parallel-Group Dose Finding Study Comparing the Safety and Efficacy of BOL-303259-X to Latanoprost in Subjects With Open Angle Glaucoma or Ocular Hypertension

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.

Inclusion Criteria:

• Subjects must have a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OH) in one or both eyes.
• IOP requirements at Visit 3, A mean/median IOP ≥ 26 mmHg at a minimum of 1 time point, ≥ 24 mmHg at a minimum of 1 time point, and ≥ 22 mmHg at 1 time point in the same eye, and Mean/median IOP ≤ 32 mmHg in both eyes at all 3 measurement time points.
• Subjects with best-corrected visual acuity (BCVA), using Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol, of +0.7 logMAR units (Snellen equivalent ~20/100) or better in either eye.

Exclusion Criteria:

• Subjects with a known hypersensitivity or contraindications to latanoprost or any of the ingredients in the study drugs.
• Subjects with known contraindications to nitric oxide (NO) treatment.
• Subjects whose central corneal thickness was greater than 600um in either eye.
• Subjects with any condition that prevented reliable applanation tonometry in either eye.
• Subjects with advanced glaucoma and subjects with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye.
• Subjects with previous or active corneal disease.
• Subjects with a history of severe dry eye.
• Subjects with monophthalmia.
• Subjects with optic disc hemorrhage.
• Subjects with a history of central retinal vein and artery occlusion.
• Subjects with a history of macular edema.
• Subjects with any intraocular infection, inflammation, or laser surgery within the previous 6 months from Visit 1 (Screening).
• Subjects who had incisional ocular surgery or severe trauma within the previous 6 months from Visit 1 (Screening).
• Subjects with very narrow angles (3 quadrants with less than Grade 2 according to Shaffer's anterior chamber angle grading system) and subjects with angle closure, congenital and secondary glaucoma, and subjects with history of angle closure in either eye.
• Subjects with a diagnosis of a clinically significant or progressive retinal disease in either eye.
• Subjects who were expected to require treatment with ocular or systemic corticosteroids.
• Subjects who were in need of any other topical or systemic treatment of OAG or OHT.
• Subjects with an anticipated need to initiate or modify medication (systemic or topical) that was known to affect IOP during the study period.