A Randomized, Multicenter, Single-Masked, Parallel-Group Dose Finding Study Comparing the Safety and Efficacy of BOL-303259-X to Latanoprost in Subjects With Open Angle Glaucoma or Ocular Hypertension

Bausch & Lomb Incorporated1 site in 1 country413 target enrollmentDecember 13, 2010

ConditionsIntraocular Pressure

InterventionsBOL-303259-X Latanoprost

DrugsBOL-303259-X Latanoprost

Overview

Phase: Phase 2
Intervention: BOL-303259-X
Conditions: Intraocular Pressure
Sponsor: Bausch & Lomb Incorporated
Enrollment: 413
Locations: 1
Primary Endpoint: Change in Mean Diurnal IOP at Visit 6 (Day 28)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 13, 2010

End Date

June 22, 2012

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bausch & Lomb Incorporated

Responsible Party

Sponsor

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.

Arms & Interventions

BOL-303259-X

ophthalmic solution

Intervention: BOL-303259-X

Latanoprost

ophthalmic solution

Intervention: Latanoprost

Outcomes

Primary Outcomes

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

Time Frame: Baseline and 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

Secondary Outcomes

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))