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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01223378

Acronym

Voyager

Enrollment

413

Registered

2010-10-19

Start date

2010-12-13

Completion date

2012-06-22

Last updated

2018-07-24

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

Conditions

Intraocular Pressure

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.

Interventions

DRUGBOL-303259-X

ophthalmic solution, various concentrations, once daily (QD) 28 days

DRUGLatanoprost

0.005% ophthalmic solution, QD 28 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in Mean Diurnal IOP at Visit 6 (Day 28)	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

Measure	Time frame	Description
Change in Mean Diurnal IOP at Visits 4,5, and 7	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
IOP </=18mm Hg	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
Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)	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)
Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	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)

Countries

United States

Participant flow

Recruitment details

First subject enrolled on 13 Dec 2010, Last subject exited on 20 Dec 2011. This study was conducted at 23 clinical sites. US \[15 sites\], Bulgaria \[3 sites\], Poland \[3 sites\], and Czech Republic \[2 sites\]).

Pre-assignment details

Subjects who were currently under treatment with an IOP-lowering medication at Visit 1 were required to discontinue the IOP medication during the washout period (minimum of 28 days) between Visit 1 and Visit 3.

Participants by arm

Arm	Count
BOL-303259-X 0.006% ophthalmic solution Experimental: BOL-303259-X: ophthalmic solution, 0.006%, once daily (QD) 28 days	82
BOL-303259-X 0.012% ophthalmic solution Experimental: BOL-303259-X: ophthalmic solution, 0.012%, once daily (QD) 28 days	85
BOL-303259-X 0.024% ophthalmic solution Experimental: BOL-303259-X: ophthalmic solution, 0.024%, once daily (QD) 28 days	83
BOL-303259-X 0.040% ophthalmic solution Experimental: BOL-303259-X: ophthalmic solution, 0.040%, once daily (QD) 28 days	81
Latanoprost ophthalmic solution Latanoprost: 0.005% ophthalmic solution, QD 28 days	82
Total	413

Baseline characteristics

Characteristic	Latanoprost	Total	BOL-303259-X 0.006%	BOL-303259-X 0.012%	BOL-303259-X 0.024%	BOL-303259-X 0.040%
Age, Continuous	61.2 years STANDARD_DEVIATION 11.92	61.0 years STANDARD_DEVIATION 11.44	60.9 years STANDARD_DEVIATION 11.39	61.6 years STANDARD_DEVIATION 9.58	60.8 years STANDARD_DEVIATION 11.47	60.3 years STANDARD_DEVIATION 12.89
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants	32 Participants	5 Participants	2 Participants	8 Participants	6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	71 Participants	381 Participants	77 Participants	83 Participants	75 Participants	75 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) Black or African American	16 Participants	104 Participants	21 Participants	23 Participants	21 Participants	23 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) White	66 Participants	306 Participants	61 Participants	61 Participants	62 Participants	56 Participants
Sex: Female, Male Female	53 Participants	255 Participants	56 Participants	46 Participants	57 Participants	43 Participants
Sex: Female, Male Male	29 Participants	158 Participants	26 Participants	39 Participants	26 Participants	38 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	0 / 82	0 / 84	0 / 83	0 / 81	0 / 82
other Total, other adverse events	20 / 82	18 / 84	20 / 83	23 / 81	10 / 82
serious Total, serious adverse events	1 / 82	0 / 84	0 / 83	0 / 81	2 / 82

Outcome results

Primary

Change in Mean Diurnal IOP at 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

Time frame: Baseline and Visit 6 (Day 28)

Population: Intent-to-treat population, observed data (study eye)

Arm	Measure	Value (MEAN)	Dispersion
BOL-303259-X 0.006%	Change in Mean Diurnal IOP at Visit 6 (Day 28)	-7.829 mm Hg	Standard Deviation 2.823
BOL-303259-X 0.012%	Change in Mean Diurnal IOP at Visit 6 (Day 28)	-8.295 mm Hg	Standard Deviation 2.864
BOL-303259-X 0.024%	Change in Mean Diurnal IOP at Visit 6 (Day 28)	-8.952 mm Hg	Standard Deviation 3.337
BOL-303259-X 0.040%	Change in Mean Diurnal IOP at Visit 6 (Day 28)	-8.894 mm Hg	Standard Deviation 2.666
Latanoprost	Change in Mean Diurnal IOP at Visit 6 (Day 28)	-7.800 mm Hg	Standard Deviation 2.834

Secondary

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

Time frame: baseline and Visit 6 (Day 28)

Population: Intent to treat, data as observed (study eye)

Arm	Measure	Group	Value (MEAN)	Dispersion
BOL-303259-X 0.006%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)	Change from Baseline (8 am)	-8.42 mm Hg	Standard Deviation 3.69
BOL-303259-X 0.006%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)	Change from Baseline (4 pm)	-7.23 mm Hg	Standard Deviation 2.97
BOL-303259-X 0.006%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)	Change from Baseline (12 pm)	-7.82 mm Hg	Standard Deviation 3.34
BOL-303259-X 0.012%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)	Change from Baseline (12 pm)	-8.33 mm Hg	Standard Deviation 3.35
BOL-303259-X 0.012%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)	Change from Baseline (8 am)	-8.91 mm Hg	Standard Deviation 3.24
BOL-303259-X 0.012%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)	Change from Baseline (4 pm)	-7.65 mm Hg	Standard Deviation 3.37
BOL-303259-X 0.024%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)	Change from Baseline (12 pm)	-8.98 mm Hg	Standard Deviation 3.5
BOL-303259-X 0.024%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)	Change from Baseline (8 am)	-9.46 mm Hg	Standard Deviation 4.01
BOL-303259-X 0.024%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)	Change from Baseline (4 pm)	-8.59 mm Hg	Standard Deviation 3.54
BOL-303259-X 0.040%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)	Change from Baseline (8 am)	-9.61 mm Hg	Standard Deviation 2.95
BOL-303259-X 0.040%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)	Change from Baseline (4 pm)	-8.47 mm Hg	Standard Deviation 3.28
BOL-303259-X 0.040%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)	Change from Baseline (12 pm)	-8.60 mm Hg	Standard Deviation 3.23
Latanoprost	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)	Change from Baseline (12 pm)	-7.63 mm Hg	Standard Deviation 3.55
Latanoprost	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)	Change from Baseline (8 am)	-8.76 mm Hg	Standard Deviation 3.24
Latanoprost	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)	Change from Baseline (4 pm)	-6.99 mm Hg	Standard Deviation 3.52

Secondary

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

Time frame: baseline and Visits 4, 5 and 7 (Days 7, 14, and 29)

Population: Intent-to-treat, observed data (study eye)

Arm	Measure	Group	Value (MEAN)	Dispersion
BOL-303259-X 0.006%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 7 (Day 29) (4 pm)	-5.575 mm Hg	Standard Deviation 3.464
BOL-303259-X 0.006%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 5 (Day 14) (12 pm)	-7.500 mm Hg	Standard Deviation 2.653
BOL-303259-X 0.006%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 4 (Day 7) (12 pm)	-6.665 mm Hg	Standard Deviation 3.046
BOL-303259-X 0.006%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 5 (Day 14) (4 pm)	-7.053 mm Hg	Standard Deviation 2.519
BOL-303259-X 0.006%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 7 (Day 29) (12 pm)	-6.039 mm Hg	Standard Deviation 3.591
BOL-303259-X 0.006%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 4 (Day 7) (4 pm)	-6.684 mm Hg	Standard Deviation 3.246
BOL-303259-X 0.006%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 7 (Day 29) (8 am)	-6.969 mm Hg	Standard Deviation 3.245
BOL-303259-X 0.006%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 5 (Day 14) (8 am)	-8.270 mm Hg	Standard Deviation 3.399
BOL-303259-X 0.006%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 4 (Day 7) (8 am)	-7.203 mm Hg	Standard Deviation 3.634
BOL-303259-X 0.012%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 7 (Day 29) (8 am)	-6.796 mm Hg	Standard Deviation 3.379
BOL-303259-X 0.012%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 5 (Day 14) (4 pm)	-6.905 mm Hg	Standard Deviation 3.354
BOL-303259-X 0.012%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 5 (Day 14) (8 am)	-8.538 mm Hg	Standard Deviation 3.518
BOL-303259-X 0.012%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 5 (Day 14) (12 pm)	-8.381 mm Hg	Standard Deviation 3.518
BOL-303259-X 0.012%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 4 (Day 7) (4 pm)	-6.902 mm Hg	Standard Deviation 3.371
BOL-303259-X 0.012%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 7 (Day 29) (4 pm)	-5.574 mm Hg	Standard Deviation 3.615
BOL-303259-X 0.012%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 4 (Day 7) (12 pm)	-7.823 mm Hg	Standard Deviation 3.409
BOL-303259-X 0.012%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 4 (Day 7) (8 am)	-8.396 mm Hg	Standard Deviation 3.935
BOL-303259-X 0.012%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 7 (Day 29) (12 pm)	-6.235 mm Hg	Standard Deviation 3.626
BOL-303259-X 0.024%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 5 (Day 14) (4 pm)	-8.310 mm Hg	Standard Deviation 3.667
BOL-303259-X 0.024%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 4 (Day 7) (8 am)	-8.667 mm Hg	Standard Deviation 3.827
BOL-303259-X 0.024%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 4 (Day 7) (12 pm)	-8.247 mm Hg	Standard Deviation 3.643
BOL-303259-X 0.024%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 4 (Day 7) (4 pm)	-7.778 mm Hg	Standard Deviation 3.479
BOL-303259-X 0.024%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 5 (Day 14) (8 am)	-9.569 mm Hg	Standard Deviation 3.597
BOL-303259-X 0.024%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 5 (Day 14) (12 pm)	-8.700 mm Hg	Standard Deviation 3.579
BOL-303259-X 0.024%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 7 (Day 29) (8 am)	-7.675 mm Hg	Standard Deviation 4.198
BOL-303259-X 0.024%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 7 (Day 29) (12 pm)	-7.119 mm Hg	Standard Deviation 3.791
BOL-303259-X 0.024%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 7 (Day 29) (4 pm)	-6.738 mm Hg	Standard Deviation 3.769
BOL-303259-X 0.040%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 5 (Day 14) (8 am)	-9.006 mm Hg	Standard Deviation 3.031
BOL-303259-X 0.040%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 5 (Day 14) (4 pm)	-8.256 mm Hg	Standard Deviation 3.41
BOL-303259-X 0.040%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 4 (Day 7) (4 pm)	-8.281 mm Hg	Standard Deviation 3.172
BOL-303259-X 0.040%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 7 (Day 29) (8 am)	-7.406 mm Hg	Standard Deviation 3.26
BOL-303259-X 0.040%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 4 (Day 7) (12 pm)	-8.219 mm Hg	Standard Deviation 3.338
BOL-303259-X 0.040%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 7 (Day 29) (4 pm)	-6.090 mm Hg	Standard Deviation 4.142
BOL-303259-X 0.040%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 7 (Day 29) (12 pm)	-6.791 mm Hg	Standard Deviation 3.246
BOL-303259-X 0.040%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 4 (Day 7) (8 am)	-8.869 mm Hg	Standard Deviation 3.384
BOL-303259-X 0.040%	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 5 (Day 14) (12 pm)	-8.556 mm Hg	Standard Deviation 3.529
Latanoprost	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 4 (Day 7) (8 am)	-8.125 mm Hg	Standard Deviation 2.826
Latanoprost	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 5 (Day 14) (8 am)	-8.519 mm Hg	Standard Deviation 3.444
Latanoprost	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 5 (Day 14) (4 pm)	-7.120 mm Hg	Standard Deviation 3.744
Latanoprost	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 4 (Day 7) (4 pm)	-6.650 mm Hg	Standard Deviation 3.312
Latanoprost	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 5 (Day 14) (12 pm)	-7.519 mm Hg	Standard Deviation 3.437
Latanoprost	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 7 (Day 29) (4 pm)	-5.715 mm Hg	Standard Deviation 3.514
Latanoprost	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 7 (Day 29) (12 pm)	-6.108 mm Hg	Standard Deviation 3.228
Latanoprost	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 7 (Day 29) (8 am)	-7.006 mm Hg	Standard Deviation 3.131
Latanoprost	Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)	Visit 4 (Day 7) (12 pm)	-7.200 mm Hg	Standard Deviation 3.386

Secondary

Change in Mean Diurnal IOP at Visits 4,5, and 7

Determine the most effective drug concentration(s) of BOL-303259-X in the reduction of intraocular pressure (IOP) and compared to latanoprost

Time frame: Baseline and Visit 4 (Day 7), Visit 5 (day 14), and Visit 7 (Day 29)

Population: Intent-to-treat population, observed data (study eye)

Arm	Measure	Group	Value (MEAN)	Dispersion
BOL-303259-X 0.006%	Change in Mean Diurnal IOP at Visits 4,5, and 7	Visit 4 (Day 7)	-6.850 mm Hg	Standard Deviation 2.768
BOL-303259-X 0.006%	Change in Mean Diurnal IOP at Visits 4,5, and 7	Visit 7 (Day 29)	-6.188 mm Hg	Standard Deviation 2.782
BOL-303259-X 0.006%	Change in Mean Diurnal IOP at Visits 4,5, and 7	Visit 5 (Day 14)	-7.607 mm Hg	Standard Deviation 2.204
BOL-303259-X 0.012%	Change in Mean Diurnal IOP at Visits 4,5, and 7	Visit 5 (Day 14)	-7.934 mm Hg	Standard Deviation 3.065
BOL-303259-X 0.012%	Change in Mean Diurnal IOP at Visits 4,5, and 7	Visit 4 (Day 7)	-7.707 mm Hg	Standard Deviation 3.192
BOL-303259-X 0.012%	Change in Mean Diurnal IOP at Visits 4,5, and 7	Visit 7 (Day 29)	-6.202 mm Hg	Standard Deviation 3.001
BOL-303259-X 0.024%	Change in Mean Diurnal IOP at Visits 4,5, and 7	Visit 5 (Day 14)	-8.859 mm Hg	Standard Deviation 3.3
BOL-303259-X 0.024%	Change in Mean Diurnal IOP at Visits 4,5, and 7	Visit 4 (Day 7)	-8.230 mm Hg	Standard Deviation 3.286
BOL-303259-X 0.024%	Change in Mean Diurnal IOP at Visits 4,5, and 7	Visit 7 (Day 29)	-7.177 mm Hg	Standard Deviation 3.615
BOL-303259-X 0.040%	Change in Mean Diurnal IOP at Visits 4,5, and 7	Visit 4 (Day 7)	-8.456 mm Hg	Standard Deviation 2.892
BOL-303259-X 0.040%	Change in Mean Diurnal IOP at Visits 4,5, and 7	Visit 7 (Day 29)	-6.846 mm Hg	Standard Deviation 3.135
BOL-303259-X 0.040%	Change in Mean Diurnal IOP at Visits 4,5, and 7	Visit 5 (Day 14)	-8.606 mm Hg	Standard Deviation 2.878
Latanoprost	Change in Mean Diurnal IOP at Visits 4,5, and 7	Visit 5 (Day 14)	-7.719 mm Hg	Standard Deviation 3.035
Latanoprost	Change in Mean Diurnal IOP at Visits 4,5, and 7	Visit 4 (Day 7)	-7.325 mm Hg	Standard Deviation 2.699
Latanoprost	Change in Mean Diurnal IOP at Visits 4,5, and 7	Visit 7 (Day 29)	-6.276 mm Hg	Standard Deviation 2.941

Secondary

IOP </=18mm Hg

Determine the number of subjects with mean diurnal IOP \</=18 mm Hg with BOL-303259-X versus latanoprost ophthalmic solution

Time frame: Visit 4 (Day 7), Visit 5 (day 14), Visit 6 (Day 28) and Visit 7 (Day 29)

Population: Intent-to-treat population, observed data (study eye)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
BOL-303259-X 0.006%	IOP </=18mm Hg	Visit 4 (Day 7)	30 Participants
BOL-303259-X 0.006%	IOP </=18mm Hg	Visit 7 (Day 29)	25 Participants
BOL-303259-X 0.006%	IOP </=18mm Hg	Visit 6 (Day 28)	41 Participants
BOL-303259-X 0.006%	IOP </=18mm Hg	Visit 5 (Day 14)	34 Participants
BOL-303259-X 0.012%	IOP </=18mm Hg	Visit 7 (Day 29)	24 Participants
BOL-303259-X 0.012%	IOP </=18mm Hg	Visit 5 (Day 14)	42 Participants
BOL-303259-X 0.012%	IOP </=18mm Hg	Visit 4 (Day 7)	37 Participants
BOL-303259-X 0.012%	IOP </=18mm Hg	Visit 6 (Day 28)	44 Participants
BOL-303259-X 0.024%	IOP </=18mm Hg	Visit 5 (Day 14)	52 Participants
BOL-303259-X 0.024%	IOP </=18mm Hg	Visit 4 (Day 7)	47 Participants
BOL-303259-X 0.024%	IOP </=18mm Hg	Visit 7 (Day 29)	37 Participants
BOL-303259-X 0.024%	IOP </=18mm Hg	Visit 6 (Day 28)	57 Participants
BOL-303259-X 0.040%	IOP </=18mm Hg	Visit 6 (Day 28)	51 Participants
BOL-303259-X 0.040%	IOP </=18mm Hg	Visit 5 (Day 14)	45 Participants
BOL-303259-X 0.040%	IOP </=18mm Hg	Visit 4 (Day 7)	46 Participants
BOL-303259-X 0.040%	IOP </=18mm Hg	Visit 7 (Day 29)	25 Participants
Latanoprost	IOP </=18mm Hg	Visit 7 (Day 29)	23 Participants
Latanoprost	IOP </=18mm Hg	Visit 4 (Day 7)	29 Participants
Latanoprost	IOP </=18mm Hg	Visit 5 (Day 14)	39 Participants
Latanoprost	IOP </=18mm Hg	Visit 6 (Day 28)	38 Participants

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

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

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Change in Mean Diurnal IOP at Visit 6 (Day 28)

Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)

Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)

Change in Mean Diurnal IOP at Visits 4,5, and 7

IOP </=18mm Hg