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

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.