FindTrial
Sign In

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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01749930
Acronym
LUNAR
Enrollment
420
Registered
2012-12-17
Start date
2013-01-31
Completion date
2015-05-31
Last updated
2018-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open-Angle Glaucoma, Ocular Hypertension

Keywords

Intraocular pressure

Brief summary

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.

Interventions

DRUGBOL-303259-X

BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning

DRUGTimolol

Timolol will be administered BID once in the morning and once in the evening.

Sponsors

Bausch & Lomb Incorporated
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 ≥ 24 mmHg at a minimum of 2 time points 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).

Design outcomes

Primary

MeasureTime frameDescription
Mean IOP8 AM, 12 PM, and 4 PM at Visit 4 (Week 2), Visit 5 (Week 6), and Visit 6 (Month 3)Mean intraocular pressure (IOP) in the 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

MeasureTime frameDescription
IOP ≤ 18 mm Hg8 AM, 12 PM, and 4 PM at Visit 4 (Week 2), Visit 5 (Week 6), and Visit 6 (Month 3)Percentage of participants with IOP ≤ 18 mm Hg consistently at all 9 time points in the first 3 months
IOP Reduction ≥ 25%8 AM, 12 PM, and 4 PM at Visit 4 (Week 2), Visit 5 (Week 6), and Visit 6 (Month 3)Percentage of participants with IOP reduction ≥ 25% consistently at all 9 time points in the first 3 months

Other

MeasureTime frameDescription
Number of Participants With Ocular and Systemic Adverse Events6 monthsFollowing assessments through 3 months (Visit 6), all participants, irrespective of previous randomization, converted to a single open label safety arm receiving BOL-303259-X QD in the evening for an additional 3 months through Visit 7. Adverse events were recorded throughout the comparative efficacy phase and open label extension phase.

Countries

United States

Participant flow

Participants by arm

ArmCount
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). BOL-303259-X: BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning 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).
278
Timolol
Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s). Timolol: Timolol will be administered BID once in the morning and once in the evening. 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).
136
Total414

Baseline characteristics

CharacteristicTimololTotalBOL-303259-X
Age, Continuous64.1 years
STANDARD_DEVIATION 9.71
64.7 years
STANDARD_DEVIATION 9.75
65.0 years
STANDARD_DEVIATION 9.77
Ethnicity (NIH/OMB)
Hispanic or Latino
19 Participants55 Participants36 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
117 Participants359 Participants242 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
1 Participants5 Participants4 Participants
Race (NIH/OMB)
Black or African American
46 Participants115 Participants69 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
89 Participants293 Participants204 Participants
Sex: Female, Male
Female
79 Participants241 Participants162 Participants
Sex: Female, Male
Male
57 Participants173 Participants116 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
50 / 27912 / 13632 / 384
serious
Total, serious adverse events
4 / 2790 / 1362 / 384

Outcome results

Primary

Mean IOP

Mean intraocular pressure (IOP) in the 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).

Time frame: 8 AM, 12 PM, and 4 PM at Visit 4 (Week 2), Visit 5 (Week 6), and Visit 6 (Month 3)

Population: Intent-to-treat population with LOCF

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
BOL-303259-XMean IOP12 pm week 218.46 mm HgStandard Deviation 3.327
BOL-303259-XMean IOP4 pm week 617.87 mm HgStandard Deviation 3.114
BOL-303259-XMean IOP8 am week 618.67 mm HgStandard Deviation 3.272
BOL-303259-XMean IOP8 am Month 318.68 mm HgStandard Deviation 3.195
BOL-303259-XMean IOP4 pm week 218.10 mm HgStandard Deviation 3.135
BOL-303259-XMean IOP12 pm Month 317.92 mm HgStandard Deviation 3.119
BOL-303259-XMean IOP12 pm week 618.02 mm HgStandard Deviation 3.073
BOL-303259-XMean IOP4 pm Month 317.72 mm HgStandard Deviation 3.153
BOL-303259-XMean IOP8 am week 219.17 mm HgStandard Deviation 3.748
TimololMean IOP4 pm Month 319.06 mm HgStandard Deviation 3.002
TimololMean IOP8 am week 219.61 mm HgStandard Deviation 3.092
TimololMean IOP12 pm week 219.22 mm HgStandard Deviation 3.241
TimololMean IOP4 pm week 218.79 mm HgStandard Deviation 3.022
TimololMean IOP8 am week 619.59 mm HgStandard Deviation 3.324
TimololMean IOP12 pm week 618.86 mm HgStandard Deviation 3.169
TimololMean IOP4 pm week 618.85 mm HgStandard Deviation 3.415
TimololMean IOP8 am Month 319.56 mm HgStandard Deviation 3.318
TimololMean IOP12 pm Month 319.21 mm HgStandard Deviation 3.129
p-value: 0.216ANCOVA
Secondary

IOP ≤ 18 mm Hg

Percentage of participants with IOP ≤ 18 mm Hg consistently at all 9 time points in the first 3 months

Time frame: 8 AM, 12 PM, and 4 PM at Visit 4 (Week 2), Visit 5 (Week 6), and Visit 6 (Month 3)

Population: Intent-to treat population with LOCF

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
BOL-303259-XIOP ≤ 18 mm Hg49 Participants
TimololIOP ≤ 18 mm Hg15 Participants
p-value: 0.084Chi-squared
Secondary

IOP Reduction ≥ 25%

Percentage of participants with IOP reduction ≥ 25% consistently at all 9 time points in the first 3 months

Time frame: 8 AM, 12 PM, and 4 PM at Visit 4 (Week 2), Visit 5 (Week 6), and Visit 6 (Month 3)

Population: Intent-to-treat population with LOCF

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
BOL-303259-XIOP Reduction ≥ 25%86 Participants
TimololIOP Reduction ≥ 25%25 Participants
p-value: 0.007Chi-squared
Other Pre-specified

Number of Participants With Ocular and Systemic Adverse Events

Following assessments through 3 months (Visit 6), all participants, irrespective of previous randomization, converted to a single open label safety arm receiving BOL-303259-X QD in the evening for an additional 3 months through Visit 7. Adverse events were recorded throughout the comparative efficacy phase and open label extension phase.

Time frame: 6 months

Population: Safety population. Of the subjects randomized, 415 instilled at least one dose of study medication and were included in the safety population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
BOL-303259-XNumber of Participants With Ocular and Systemic Adverse Events>/= 1 nonocular AE36 Participants
BOL-303259-XNumber of Participants With Ocular and Systemic Adverse Events>/= 1 ocular (Study eye) AE66 Participants
TimololNumber of Participants With Ocular and Systemic Adverse Events>/= 1 nonocular AE18 Participants
TimololNumber of Participants With Ocular and Systemic Adverse Events>/= 1 ocular (Study eye) AE18 Participants
BOL-303259-X Safety Extension PhaseNumber of Participants With Ocular and Systemic Adverse Events>/= 1 nonocular AE23 Participants
BOL-303259-X Safety Extension PhaseNumber of Participants With Ocular and Systemic Adverse Events>/= 1 ocular (Study eye) AE53 Participants

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026