Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Condition: Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: BOL-303259-X; Timolol; BOL-303259-X
Intervention description: Topical ocular BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning for 3 months (visit 6).; Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6); All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)
Intervention MeSH terms: Timolol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 420.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Intraocular pressure

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 9 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).