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CompletedNCT01707381ConstellationUpdated Sep 4, 2018Results posted

BOL-303259-X With Timolol 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension

A Phase 2 interventional study of BOL-303259-X and Timolol maleate in Ocular Hypertension and Open Angle Glaucoma, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-09-04.

Sponsored by Bausch & Lomb Incorporated · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
40 Years to 90 Years
Sex
All
01

Study summary

This clinical investigation is being performed to compare the effect of BOL-303259-X dosed once daily (QD) with timolol maleate 0.5% dosed twice daily (BID) in reducing intraocular pressure (IOP) measured over a 24-hour period in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).

02

Conditions studied

  • Ocular Hypertension
  • Open Angle Glaucoma
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 25 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Bausch & Lomb Incorporated is the lead sponsor of 219 studies on the registry; 7 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 41 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects must have a diagnosis of OAG or OHT in 1 or both eyes.
  • Subjects who are treatment-naïve must meet the following IOP requirements at Visit 1 (Screening), and pretreated subjects must meet the following IOP requirements at Visit 2 (Washout): Intraocular pressure ≥ 22 mmHg in at least 1 eye and ≤ 36 mmHg in both eyes.

Exclusion criteria

Exclusion Criteria:

  • Subjects who have been exposed to BOL-303259-X within 3 months prior to Visit 1 (Screening).
  • Subjects with a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the results of the study.
  • Subjects with an irregular daily sleep schedule.
  • Subjects who are unable to wear sleep monitoring device for 7 days prior to laboratory study.
  • Subjects with an anticipated need to initiate or modify medication (systemic or topical) that is known to affect IOP.
  • Subjects for whom concomitant use of medications may interact with the safety or efficacy of a nitric oxide.
  • Subjects with known hypersensitivity or contraindications to latanoprost or any of the ingredients in the study drugs.
  • Subjects who are expected to require treatment with ocular or systemic corticosteroids.
  • Subjects who are in need of any other topical or systemic treatment of OAG or OHT.
  • Subjects who are unable to discontinue contact lens use during and for 24 hours before the laboratory study.
  • Subjects with a central corneal thickness greater than 600 μm in either eye.
  • Subjects with any condition that prevents reliable applanationtonometry 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 active optic disc hemorrhage.
  • Subjects with a history of central/branch retinal vein or artery occlusion.
  • Subjects with a history of macular edema.
  • Subjects with very narrow angles 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 with any intraocular infection or inflammation within 3 months prior to Visit 1 (Screening).
  • Subjects with a history of ocular laser surgery within the 3 months prior to Visit 1 (Screening).
  • Subjects with a history of incisional ocular surgery or severe trauma within 3 months prior to Visit 1 (Screening).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Active comparator
    Timolol Maleate

    Timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks.

    Drug: Timolol maleate

  • Experimental
    BOL-303259-X

    BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks.

    Drug: BOL-303259-X

Interventions

  • DrugBOL-303259-X

    Topical ophthalmic solution

  • DrugTimolol maleate

    Topical ophthalmic solution

06

What researchers measure

Primary outcomes

  1. 24 Hour IOP

    Supine intraocular pressure (IOP) measured in the study eye following 4 weeks of treatment

    Time frame: after 4 weeks of treatment

Secondary outcomes

  1. 24-hour Ocular Perfusion Pressure

    Sitting Ocular Perfusion Pressure = 95/140 x mean arterial blood pressure - IOP; Supine Ocular Perfusion Pressure = 115/130 x mean arterial blood pressure - IOP; the nocturnal time frame encompassed measures taken at 10pm, 12am, 2am and 4 am; whereas the diurnal time frame encompassed measures taken at 6am, 8am, 10am, 12pm, 2pm, 4pm, 6pm, and 8pm.

    Time frame: after 4 weeks of treatment

  2. IOP Area Under the Curve Over 24 Hours

    The Area Under the Curve(AUC) is the weighted average of IOP over all 24-hour IOP assessment times (2pm, 4pm, 6pm, 8pm, 10pm, 12am, 2am, 4am, 6am, 8am, 10am, 12pm). The AUC was calculated using the trapezoidal rule.

    Time frame: after 4 weeks of treatment

07

Results

Posted Sep 4, 2018

Participant flow

Period 1
Participant flow — Period 1
MilestoneTimolol Maleate Cross Over to BOL-303259XBOL-303259-X Crossover to Timolol Maleate
Started1213
Completed1011
Not completed22
Period 2
Participant flow — Period 2
MilestoneTimolol Maleate Cross Over to BOL-303259XBOL-303259-X Crossover to Timolol Maleate
Started1011
Completed1011
Not completed00

Outcome measures

Primary24 Hour IOP

Supine intraocular pressure (IOP) measured in the study eye following 4 weeks of treatment

Time frame:
after 4 weeks of treatment
Reported as:
Least squares mean · mm Hg
24 Hour IOP
mm HgTimolol MaleateBOL-303259-X
24 Hour IOP23.55 ± 2.4621.77 ± 2.37
Statistical analysis
  • Timolol Maleate vs BOL-303259-X · ANCOVA · p = <0.001 · Treatment difference: -1.773 · 95% CI -2.380 to -1.166Treatment Difference = BOL-303259-X 0.024% - Timolol maleate 0.5%.
Secondary24-hour Ocular Perfusion Pressure

Sitting Ocular Perfusion Pressure = 95/140 x mean arterial blood pressure - IOP; Supine Ocular Perfusion Pressure = 115/130 x mean arterial blood pressure - IOP; the nocturnal time frame encompassed measures taken at 10pm, 12am, 2am and 4 am; whereas the diurnal time frame encompassed measures taken at 6am, 8am, 10am, 12pm, 2pm, 4pm, 6pm, and 8pm.

Time frame:
after 4 weeks of treatment
Reported as:
Mean · mm Hg
24-hour Ocular Perfusion Pressure
mm HgTimolol MaleateBOL-303259-X
OPP (nocturnal)48.4 ± 9.452.5 ± 9.5
OPP (Diurnal supine)54.8 ± 7.555.9 ± 7.8
OPP (Diurnal sitting)43.2 ± 5.745.2 ± 6.8
Statistical analysis
  • Timolol Maleate vs BOL-303259-X · ANOVA · p = <0.05 · Bonferroni t-test used for paired compar: 0.010the bonferroni result applies to nocturnal supine OPP data comparing BOL group to timolol group
SecondaryIOP Area Under the Curve Over 24 Hours

The Area Under the Curve(AUC) is the weighted average of IOP over all 24-hour IOP assessment times (2pm, 4pm, 6pm, 8pm, 10pm, 12am, 2am, 4am, 6am, 8am, 10am, 12pm). The AUC was calculated using the trapezoidal rule.

Time frame:
after 4 weeks of treatment
Reported as:
Least squares mean · mm Hg
IOP Area Under the Curve Over 24 Hours
mm HgTimolol MaleateBOL-303259-X
IOP Area Under the Curve Over 24 Hours23.54 ± 2.4421.77 ± 2.29
Statistical analysis
  • Timolol Maleate vs BOL-303259-X · ANOVA · p = 0.004 · Mean difference (final values): -1.770 · 95% CI -2.915 to -0.625Treatment Difference = BOL-303259-X 0.024% - Timolol maleate 0.5%.

Adverse events

Collected over Four weeks for each intervention. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Timolol Maleate0/23 (0%)0/23 (0%)4/23 (17.4%)
BOL-303259-X0/23 (0%)0/23 (0%)1/23 (4.3%)
Most frequent other events
Most frequent other events
EventTimolol MaleateBOL-303259-X
Punctate keratitisEye disorders3/230/23
Instillation site erythemaGeneral disorders0/231/23
Instillation site irritationsGeneral disorders1/230/23
DizzinessCardiac disorders1/230/23
DyspnoeaCardiac disorders1/230/23
NauseaGastrointestinal disorders1/231/23
hyperhidrosisGeneral disorders0/231/23
Blood pressure decreasedInvestigations1/230/23
Heart rate decreasedInvestigations1/230/23

Baseline characteristics

ITT Population: All randomized subjects who received at least one dose of study drug, had a baseline and at least one postbaseline intraocular assessment.

Age, Categorical
Age, Categorical(Participants)All Study Participants
<=18 years0
Between 18 and 65 years13
>=65 years8
Age, Continuous
Age, Continuous(years)All Study Participants
Mean61.0 ± 11.13
Sex: Female, Male
Sex: Female, Male(Participants)All Study Participants
Female14
Male7
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)All Study Participants
Hispanic or Latino4
Not Hispanic or Latino17
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Study Participants
American Indian or Alaska Native1
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American2
White18
More than one race0
Unknown or Not Reported0
Treatment-Naive
Treatment-Naive(Participants)All Study Participants
Count of participants15
08

Study locations

1 site
  • University of California San Diego
    La Jolla, California 92093, United States
09

References and documents

Publications

  • Liu JHK, Slight JR, Vittitow JL, Scassellati Sforzolini B, Weinreb RN. Efficacy of Latanoprostene Bunod 0.024% Compared With Timolol 0.5% in Lowering Intraocular Pressure Over 24 Hours. Am J Ophthalmol. 2016 Sep;169:249-257. doi: 10.1016/j.ajo.2016.04.019. Epub 2016 Jul 22. PubMed 27457257 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01707381
Lead sponsor
Bausch & Lomb Incorporated
Responsible party
Sponsor
First posted
Oct 16, 2012
Start date
Nov 2012
Primary completion
Dec 2013
Completion
Feb 2014
Results posted
Sep 4, 2018
Last update
Sep 4, 2018

Study contacts

Quintus Ngumah, OD, PhD
study director · Bausch & Lomb Incorporated

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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