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 (LUNAR)

• IOP ≤ 18 mm Hg [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  Proportion of participants with IOP ≤ 18 mm Hg consistently at all 9 time points in the first 3 months
• IOP reduction ≥ 25% [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  Proportion of participants with IOP reduction ≥ 25% consistently at all 9 time points in the first 3 months

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.

• Open-Angle Glaucoma
• Ocular Hypertension

• 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).

• Experimental: BOL-303259-X
  BOL-303259-X 0.024% ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s).
  Interventions:

  • Drug: BOL-303259-X
  • Drug: BOL-303259-X
• Active Comparator: Timolol
  Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).
  Interventions:

  • Drug: Timolol
  • Drug: BOL-303259-X

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 ≥ 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
• 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).