Clinical trial NCT01707381 (phase 2, status: completed)
Conditions: ocular hypertension, open angle glaucoma
ICD codes: H40.053, H40.051, H40.052, H40.059, H40.10X0, H40.10X1, H40.10X2, H40.10X3, H40.10X4, H40.1130, H40.1131
Drugs: bol-303259-x, timolol maleate
SMILES: O[C@H](CC[C@H]1[C@H](O)C[C@H](O)[C@@H]1C\C=C/CCCC(=O)OCCCCO[N+]([O-])=O)CCC1=CC=CC=C1, [H][C@](O)(CNC(C)(C)C)COC1=NSN=C1N1CCOCC1
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).