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

Primary Purpose

Intraocular Pressure

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

BOL-303259-X

Latanoprost

About this trial

This is an interventional screening trial for Intraocular Pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Bausch & Lomb, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BOL-303259-X

Latanoprost

Arm Description

ophthalmic solution

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

IOP </=18mm Hg

Determine the number of subjects with mean diurnal IOP </=18 mm Hg with BOL-303259-X versus latanoprost ophthalmic solution

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)

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)

Full Information

NCT ID

NCT01223378

First Posted

October 11, 2010

Last Updated

June 27, 2018

Sponsor

Bausch & Lomb Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01223378

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

December 13, 2010 (Actual)

Primary Completion Date

December 20, 2011 (Actual)

Study Completion Date

June 22, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bausch & Lomb Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intraocular Pressure

7. Study Design

Primary Purpose

Screening

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

413 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BOL-303259-X

Arm Type

Experimental

Arm Description

ophthalmic solution

Arm Title

Latanoprost

Arm Type

Active Comparator

Arm Description

ophthalmic solution

Intervention Type

Drug

Intervention Name(s)

BOL-303259-X

Other Intervention Name(s)

latanoprostene bunod

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Latanoprost

Other Intervention Name(s)

Xalatan

Intervention Description

0.005% ophthalmic solution, QD 28 days

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Baseline and Visit 6 (Day 28)

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Title

IOP </=18mm Hg

Description

Determine the number of subjects with mean diurnal IOP </=18 mm Hg with BOL-303259-X versus latanoprost ophthalmic solution

Time Frame

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

Title

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

Description

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)

Time Frame

baseline and Visit 6 (Day 28)

Title

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

Description

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)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rabia Ozden, MD

Organizational Affiliation

Bausch & Lomb Incorporated

Official's Role

Study Director

Facility Information:

Facility Name

Bausch & Lomb, Inc

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25488946

Citation

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.

Results Reference

result

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

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