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

NCT01223378 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 659
• Study Type: interventional
• Target: 413
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Mean Diurnal IOP at Visit 6 (Day 28)

  Determine the most effective drug concentration(s) of BOL-303259-X in the reduction of intraocular pressure (IOP) and compared to latanoprost

  Baseline and Visit 6 (Day 28)

Secondary Outcomes (4)

• Change in Mean Diurnal IOP at Visits 4,5, and 7

  Baseline and Visit 4 (Day 7), Visit 5 (day 14), and Visit 7 (Day 29)

• IOP </=18mm Hg

  Visit 4 (Day 7), Visit 5 (day 14), Visit 6 (Day 28) and Visit 7 (Day 29)

• Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)

  baseline and Visit 6 (Day 28)

• Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)

  baseline and Visits 4, 5 and 7 (Days 7, 14, and 29)

Study Arms (2)

BOL-303259-X

EXPERIMENTAL

ophthalmic solution

Drug: BOL-303259-X

Latanoprost

ACTIVE COMPARATOR

ophthalmic solution

Drug: Latanoprost

Interventions

BOL-303259-X DRUG

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

Also known as: latanoprostene bunod

BOL-303259-X

Latanoprost DRUG

0.005% ophthalmic solution, QD 28 days

Also known as: Xalatan

Latanoprost

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb, Inc

Rochester, New York, 14609, United States

Location

Related Publications (1)

• 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.

  PMID: 25488946 RESULT

MeSH Terms

Interventions

BOL 303259-X; Latanoprost

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: H DeCory, PhD
• Organization: Bausch & Lomb

heleen.decory@bausch.com

585-338-8161

Study Officials

• Rabia Ozden, MD

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2010
• First Posted: October 19, 2010
• Study Start: December 13, 2010
• Primary Completion: December 20, 2011
• Study Completion: June 22, 2012
• Last Updated: July 24, 2018
• Results First Posted: July 24, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)