Study Comparing the Safety and Efficacy of BOL-303259-X to Latanoprost in Subjects With Glaucoma or Ocular Hypertension
Condition: Intraocular Pressure
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: BOL-303259-X; Latanoprost
Intervention description: ophthalmic solution, various concentrations, once daily (QD) 28 days; 0.005% ophthalmic solution, QD 28 days
Intervention MeSH terms: Latanoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 413.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.