BOL-303259-X With Timolol 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension

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).