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

October 12, 2012
November 22, 2013
November 2012
December 2013   (final data collection date for primary outcome measure)
IOP [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
IOP measured in the study eye following 4 weeks of treatment
Same as current
Complete list of historical versions of study NCT01707381 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
BOL-303259-X With Timolol 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension
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.

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ocular Hypertension
  • Open Angle Glaucoma
  • Drug: BOL-303259-X
    Topical ophthalmic solution
  • Drug: Timolol maleate
    Topical ophthalmic solution
  • 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.
    Intervention: Drug: Timolol maleate
  • Experimental: BOL-303259-X
    BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks.
    Intervention: Drug: BOL-303259-X
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
February 2014
December 2013   (final data collection date for primary outcome measure)

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).
Both
40 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01707381
803
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Quintus Ngumah, OD, PhD Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP