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

Intraocular Pressure Clinical Trial

— Voyager  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223378
• Other study ID #: 659
• Status: Completed
• Phase: Phase 2
• Start date: December 13, 2010
• Est. completion date: June 22, 2012

Study information

• Verified date: June 2018
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 413
• Est. completion date: June 22, 2012
• Est. primary completion date: December 20, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Intraocular Pressure
• Ocular Hypertension

Intervention

Drug:
• BOL-303259-X
ophthalmic solution, various concentrations, once daily (QD) 28 days
• Latanoprost
0.005% ophthalmic solution, QD 28 days

Locations

Country	Name	City	State
United States	Bausch & Lomb, Inc	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

References & 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 VOY — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Mean Diurnal IOP at Visits 4,5, and 7	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 4 (Day 7), Visit 5 (day 14), and Visit 7 (Day 29)
Secondary	IOP </=18mm Hg	Determine the number of subjects with mean diurnal IOP	Visit 4 (Day 7), Visit 5 (day 14), Visit 6 (Day 28) and Visit 7 (Day 29)
Secondary	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)	The change in the observed mean study eye IOP from baseline (Visit 3, Day 1) at specified time points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)	baseline and Visit 6 (Day 28)
Secondary	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	The change in the observed mean study eye IOP from baseline (Visit 3, Day 1) at specified time points (points 8 AM, 12 PM, and 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)