Comparing the Safety and Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension (LUNAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Bausch & Lomb Incorporated
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01749930
First received: December 11, 2012
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

In participants with a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT), the primary objective is to demonstrate that the mean IOP reduction after 3 months of treatment with BOL-303259-X once daily (QD) is non-inferior to timolol maleate 0.5% twice daily (BID). The secondary objective is to demonstrate the superiority of BOL-303259-X QD to timolol maleate 0.5% BID. This assessment will be performed if the non-inferiority of BOL-303259-X QD to timolol maleate 0.5% BID is determined. An open label safety phase will be conducted at the end of Visit 6 (3 months) where all participants will receive BOL-303259-X QD for an additional 3 months.


Condition Intervention Phase
Open-Angle Glaucoma
Ocular Hypertension
Drug: BOL-303259-X
Drug: Timolol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-Masked, Parallel-Group Study Comparing the Safety and Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Mean IOP Reduction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Mean intraocular pressure (IOP) in study eye measured at the specified time points: 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).


Secondary Outcome Measures:
  • IOP ≤ 18 mm Hg [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Proportion of participants with IOP ≤ 18 mm Hg consistently at all 9 time points in the first 3 months

  • IOP reduction ≥ 25% [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Proportion of participants with IOP reduction ≥ 25% consistently at all 9 time points in the first 3 months


Other Outcome Measures:
  • Incidence of Adverse events [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Following assessments through 3 months (Visit 6), all participants, irrespective of previous randomization, will convert to a single open label safety arm receiving BOL-303259-X QD in the evening for an additional 3 months Visit 6 through Visit 7. Adverse events will be recorded.


Estimated Enrollment: 393
Study Start Date: January 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BOL-303259-X
BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s).
Drug: BOL-303259-X
BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning
Drug: BOL-303259-X
All participants will receive a topical ocular BOL-303259-X QD in the evening from 3 months (Visit 6) through 6 months (Visit7).
Active Comparator: Timolol
Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).
Drug: Timolol
Timolol will be administered BID once in the morning and once in the evening.
Drug: BOL-303259-X
All participants will receive a topical ocular BOL-303259-X QD in the evening from 3 months (Visit 6) through 6 months (Visit7).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have a diagnosis of OAG (including pigmentary or pseudoexfoliative) or OHT in 1 or both eyes.
  • Participants must meet the following IOP requirements at Visit 3
  • 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
  • IOP ≤ 36 mmHg at all 3 measurement time points in both eyes.
  • Participants with a best-corrected visual acuity (BCVA), using the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol, of +0.7 logMAR units (Snellen equivalent of approximately 20/100) or better in either eye.

Exclusion Criteria:

  • Participants with known hypersensitivity or contraindications to latanoprost, NO treatment, timolol maleate, other beta-adrenergic receptor antagonists or any of the ingredients in the study drugs.
  • Participants with a central corneal thickness greater than 600 μm in either eye.
  • Participants with advanced glaucoma and participants with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye.
  • Participants who do not have an intact posterior capsule in either eye .
  • Participants with aphakia in either eye.
  • Participants with previous or active corneal disease in either eye.
  • Participants with current or a history of severe dry eye in either eye.
  • Participants with current or a history of optic disc hemorrhage in either eye.
  • Participants with current or a history of central/branch retinal vein or artery occlusion in either eye.
  • Participants with current or a history of macular edema in either eye.
  • Participants with very narrow angles (3 quadrants with less than Grade 2 according to Shaffer's anterior chamber angle grading system) and participants with angle closure,congenital, and secondary glaucoma, and participants with history of angle closure in either eye.
  • Participants with a diagnosis of a clinically significant or progressive retinal disease in either eye.
  • Participants with any intraocular infection or inflammation in either eye within 3 months(90 days) prior to Visit 1 (Screening).
  • Participants with a history of ocular laser surgery in either eye within the 3 months(90 days) prior to Visit 1 (Screening).
  • Participants with a history of incisional ocular surgery or severe trauma in either eye within 3 months (90 days) prior to Visit 1 (Screening).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749930

Contacts
Contact: Kim Rossman, MBA (973) 360-6412 kimberly.rossman@bausch.com

Locations
United States, New York
Bausch & Lomb Inc. Recruiting
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Jason Vittitow Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01749930     History of Changes
Other Study ID Numbers: 770
Study First Received: December 11, 2012
Last Updated: November 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bausch & Lomb Incorporated:
Intraocular pressure

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014