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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01707381
First received: October 12, 2012
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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).


Condition Intervention Phase
Ocular Hypertension
Open Angle Glaucoma
Drug: BOL-303259-X
Drug: Timolol maleate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • IOP [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    IOP measured in the study eye following 4 weeks of treatment


Secondary Outcome Measures:
  • Ocular Perfusion Pressure [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
    Ocular Perfusion Pressure (OPP)(1/3 systolic blood pressure + 2/3 diastolic blood pressure) × 2/3 - IOP.

  • Area Under the Curve [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The Area Under the Curve(AUC) is the weighted average of IOP over the total IOP assessment time. The AUC will be calculated using the trapezoidal rule.


Enrollment: 25
Study Start Date: November 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Topical ophthalmic solution
Experimental: BOL-303259-X
BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks.
Drug: BOL-303259-X
Topical ophthalmic solution

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707381

Locations
United States, California
University of California San Diego
La Jolla, California, United States, 92093
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: NCT01707381     History of Changes
Other Study ID Numbers: 803
Study First Received: October 12, 2012
Last Updated: November 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Maleic acid
Timolol
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on October 01, 2014