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

NCT ID: NCT01223378

Last Updated: 2018-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 413 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-13
• Study Completion Date: 2012-06-22

Brief Summary

The objective of this clinical investigation is to determine the most effective drug concentration(s) of BOL-303259-X in the reduction of IOP in order to support further clinical development of an appropriate dose with regard to efficacy, and ocular and systemic safety.

Conditions

Intraocular Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

BOL-303259-X

ophthalmic solution

Group Type: EXPERIMENTAL

BOL-303259-X

Intervention Type: DRUG

ophthalmic solution, various concentrations, once daily (QD) 28 days

Latanoprost

ophthalmic solution

Group Type: ACTIVE_COMPARATOR

Latanoprost

Intervention Type: DRUG

0.005% ophthalmic solution, QD 28 days

Interventions

BOL-303259-X

ophthalmic solution, various concentrations, once daily (QD) 28 days

Intervention Type: DRUG

Latanoprost

0.005% ophthalmic solution, QD 28 days

Intervention Type: DRUG

Other Intervention Names

latanoprostene bunod; Xalatan

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rabia Ozden, MD

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Bausch & Lomb, Inc

Rochester, New York, United States

Countries

United States

References

Weinreb RN, Ong T, Scassellati Sforzolini B, Vittitow JL, Singh K, Kaufman PL; VOYAGER study group. A randomised, controlled comparison of latanoprostene bunod and latanoprost 0.005% in the treatment of ocular hypertension and open angle glaucoma: the VOYAGER study. Br J Ophthalmol. 2015 Jun;99(6):738-45. doi: 10.1136/bjophthalmol-2014-305908. Epub 2014 Dec 8.

Reference Type: RESULT

PMID: 25488946 (View on PubMed)

Other Identifiers

659

Identifier Type: -

Identifier Source: org_study_id