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

Primary Purpose

Ocular Hypertension, Open Angle Glaucoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BOL-303259-X
Timolol maleate
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Hypertension

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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).

Sites / Locations

  • University of California San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Timolol Maleate

BOL-303259-X

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 12, 2012
Last Updated
August 3, 2018
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01707381
Brief Title
BOL-303259-X With Timolol 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Acronym
Constellation
Official Title
A Randomized, Single-Center, Open-Label, Crossover Study Comparing the Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Open Angle Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Timolol Maleate
Arm Type
Active Comparator
Arm Description
Timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks.
Arm Title
BOL-303259-X
Arm Type
Experimental
Arm Description
BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
BOL-303259-X
Intervention Description
Topical ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Timolol maleate
Intervention Description
Topical ophthalmic solution
Primary Outcome Measure Information:
Title
24 Hour IOP
Description
Supine intraocular pressure (IOP) measured in the study eye following 4 weeks of treatment
Time Frame
after 4 weeks of treatment
Secondary Outcome Measure Information:
Title
24-hour Ocular Perfusion Pressure
Description
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
Title
IOP Area Under the Curve Over 24 Hours
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quintus Ngumah, OD, PhD
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27457257
Citation
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.
Results Reference
result

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

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