BOL-303259-X With Timolol 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Condition: Ocular Hypertension; Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: BOL-303259-X; Timolol maleate
Intervention description: Topical ophthalmic solution; Topical ophthalmic solution
Intervention MeSH terms: Timolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 40 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      This clinical investigation is being performed to compare the effect of BOL-303259-X dosed
      once daily (QD) with timolol maleate 0.5% dosed twice daily (BID) in reducing intraocular
      pressure (IOP) measured over a 24-hour period in subjects with open-angle glaucoma (OAG) or
      ocular hypertension (OHT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have a diagnosis of OAG or OHT in 1 or both eyes.

          -  Subjects who are treatment-naïve must meet the following IOP requirements at Visit 1
             (Screening), and pretreated subjects must meet the following IOP requirements at Visit
             2 (Washout): Intraocular pressure ≥ 22 mmHg in at least 1 eye and ≤ 36 mmHg in both
             eyes.

        Exclusion Criteria:

          -  Subjects who have been exposed to BOL-303259-X within 3 months prior to Visit 1
             (Screening).

          -  Subjects with a history or presence of chronic generalized systemic disease that the
             Investigator feels might increase the risk to the subject or confound the results of
             the study.

          -  Subjects with an irregular daily sleep schedule.

          -  Subjects who are unable to wear sleep monitoring device for 7 days prior to laboratory
             study.

          -  Subjects with an anticipated need to initiate or modify medication (systemic or
             topical) that is known to affect IOP.

          -  Subjects for whom concomitant use of medications may interact with the safety or
             efficacy of a nitric oxide.

          -  Subjects with known hypersensitivity or contraindications to latanoprost or any of the
             ingredients in the study drugs.

          -  Subjects who are expected to require treatment with ocular or systemic
             corticosteroids.

          -  Subjects who are in need of any other topical or systemic treatment of OAG or OHT.

          -  Subjects who are unable to discontinue contact lens use during and for 24 hours before
             the laboratory study.

          -  Subjects with a central corneal thickness greater than 600 μm in either eye.

          -  Subjects with any condition that prevents reliable applanationtonometry 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 active optic disc hemorrhage.

          -  Subjects with a history of central/branch retinal vein or artery occlusion.

          -  Subjects with a history of macular edema.

          -  Subjects with very narrow angles 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 with any intraocular infection or inflammation within 3 months prior to Visit
             1 (Screening).

          -  Subjects with a history of ocular laser surgery within the 3 months prior to Visit 1
             (Screening).

          -  Subjects with a history of incisional ocular surgery or severe trauma within 3 months
             prior to Visit 1 (Screening).