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

This study is currently recruiting participants.
Verified May 2013 by Bausch & Lomb Incorporated
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01707381
First received: October 12, 2012
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

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.


Estimated Enrollment: 24
Study Start Date: December 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707381

Contacts
Contact: Gregory Bergonio 973-360-6443 Gregory.Bergonio@bausch.com

Locations
United States, California
University of California San Diego Recruiting
La Jolla, California, United States, 92093
Contact         momoshtaghi@ucsd.edu    
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: May 14, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013