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 May 2013 by Bausch & Lomb Incorporated
Sponsor:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01749930
First received: December 11, 2012
Last updated: May 14, 2013
Last verified: May 2013
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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 0.024% 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: Gregory Bergonio | 973 360 6443 | Gregory.Bergonio@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: | Quintus Ngumah, OD, PhD | 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: | May 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bausch & Lomb Incorporated:
|
Intraocular pressure |
Additional relevant MeSH terms:
|
Hypertension Ocular Hypertension Glaucoma Glaucoma, Open-Angle 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 May 19, 2013