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

NCT ID: NCT01707381

Last Updated: 2018-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-02-28

Brief 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).

Conditions

Ocular Hypertension; Open Angle Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Timolol Maleate

Timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks.

Group Type: ACTIVE_COMPARATOR

Timolol maleate

Intervention Type: DRUG

Topical ophthalmic solution

BOL-303259-X

BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks.

Group Type: EXPERIMENTAL

BOL-303259-X

Intervention Type: DRUG

Topical ophthalmic solution

Interventions

BOL-303259-X

Topical ophthalmic solution

Intervention Type: DRUG

Timolol maleate

Topical ophthalmic solution

Intervention Type: DRUG

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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Quintus Ngumah, OD, PhD

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

University of California San Diego

La Jolla, California, United States

Countries

United States

References

Liu JHK, Slight JR, Vittitow JL, Scassellati Sforzolini B, Weinreb RN. Efficacy of Latanoprostene Bunod 0.024% Compared With Timolol 0.5% in Lowering Intraocular Pressure Over 24 Hours. Am J Ophthalmol. 2016 Sep;169:249-257. doi: 10.1016/j.ajo.2016.04.019. Epub 2016 Jul 22.

Reference Type: RESULT

PMID: 27457257 (View on PubMed)

Other Identifiers

803

Identifier Type: -

Identifier Source: org_study_id