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

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch & Lomb Incorporated
• Treatments: Maleic acid; Ophthalmic Solutions; Pharmaceutical Solutions; Timolol

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).