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.
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
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 April 22, 2014