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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01223378
Recruitment Status : Completed
First Posted : October 19, 2010
Results First Posted : July 24, 2018
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

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.

Condition or disease Intervention/treatment Phase
Intraocular Pressure Drug: BOL-303259-X Drug: Latanoprost Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 413 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Screening
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
Actual Study Start Date : December 13, 2010
Actual Primary Completion Date : December 20, 2011
Actual Study Completion Date : June 22, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: BOL-303259-X
ophthalmic solution
Drug: BOL-303259-X
ophthalmic solution, various concentrations, once daily (QD) 28 days
Other Name: latanoprostene bunod

Active Comparator: Latanoprost
ophthalmic solution
Drug: Latanoprost
0.005% ophthalmic solution, QD 28 days
Other Name: Xalatan




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in Mean Diurnal IOP at Visits 4,5, and 7 [ Time Frame: Baseline and Visit 4 (Day 7), Visit 5 (day 14), and Visit 7 (Day 29) ]
    Determine the most effective drug concentration(s) of BOL-303259-X in the reduction of intraocular pressure (IOP) and compared to latanoprost

  2. IOP </=18mm Hg [ Time Frame: Visit 4 (Day 7), Visit 5 (day 14), Visit 6 (Day 28) and Visit 7 (Day 29) ]
    Determine the number of subjects with mean diurnal IOP </=18 mm Hg with BOL-303259-X versus latanoprost ophthalmic solution

  3. Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28) [ Time Frame: baseline and 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)

  4. Change in IOP at Specified Time Points (8 AM, 12 PM, 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) ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01223378


Locations
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United States, New York
Bausch & Lomb, Inc
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
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Study Director: Rabia Ozden, MD Bausch & Lomb Incorporated
Publications of Results:
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01223378    
Other Study ID Numbers: 659
First Posted: October 19, 2010    Key Record Dates
Results First Posted: July 24, 2018
Last Update Posted: July 24, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Ophthalmic Solutions
Pharmaceutical Solutions