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Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT01177098
Recruitment Status : Completed
First Posted : August 6, 2010
Results First Posted : March 12, 2013
Last Update Posted : March 29, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE August 4, 2010
First Posted Date  ICMJE August 6, 2010
Results First Submitted Date  ICMJE February 7, 2013
Results First Posted Date  ICMJE March 12, 2013
Last Update Posted Date March 29, 2013
Study Start Date  ICMJE October 2010
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2013)
  • Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 [ Time Frame: Baseline, Week 12 ]
    Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).
  • Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2 [ Time Frame: Week 2 ]
    Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8.
  • Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6 [ Time Frame: Week 6 ]
    Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8.
  • Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 [ Time Frame: Week 12 ]
    Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8.
Original Primary Outcome Measures  ICMJE
 (submitted: August 5, 2010)
Intraocular Pressure [ Time Frame: Week 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2013)
  • Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 [ Time Frame: Baseline, Week 12 ]
    Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).
  • Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 [ Time Frame: Baseline, Week 12 ]
    Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8. Average eye IOP is defined as the average of the IOP in both eyes. A negative number change from baseline indicates a reduction in IOP (improvement).
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Official Title  ICMJE Not Provided
Brief Summary This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks in patients with glaucoma or ocular hypertension.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: bimatoprost /timolol formulation A fixed combination ophthalmic solution
    One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
  • Drug: bimatoprost/timolol fixed combination ophthalmic solution
    One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
    Other Name: GANFORT®
Study Arms  ICMJE
  • Experimental: bimatoprost/timolol formulation A
    One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
    Intervention: Drug: bimatoprost /timolol formulation A fixed combination ophthalmic solution
  • Active Comparator: bimatoprost/timolol fixed combination ophthalmic solution
    One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
    Intervention: Drug: bimatoprost/timolol fixed combination ophthalmic solution
Publications * Goldberg I, Gil Pina R, Lanzagorta-Aresti A, Schiffman RM, Liu C, Bejanian M. Bimatoprost 0.03%/timolol 0.5% preservative-free ophthalmic solution versus bimatoprost 0.03%/timolol 0.5% ophthalmic solution (Ganfort) for glaucoma or ocular hypertension: a 12-week randomised controlled trial. Br J Ophthalmol. 2014 Jul;98(7):926-31. doi: 10.1136/bjophthalmol-2013-304064. Epub 2014 Mar 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2012)
561
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2010)
500
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient has ocular hypertension or glaucoma in both eyes
  • Requires IOP-lowering therapy in each eye

Exclusion Criteria:

  • Active or recurrent eye disease that would interfere with interpretation of study data in either eye
  • History of any eye surgery or laser in either eye within 6 months
  • Required chronic use of other eye medications during the study
  • Anticipated wearing of contact lenses during the study.
  • Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Czech Republic,   Germany,   Hungary,   Israel,   Russian Federation,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01177098
Other Study ID Numbers  ICMJE 192024-050
2010-021507-24 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Allergan
Original Responsible Party Therapeutic Area Head, Allergan, Inc.
Current Study Sponsor  ICMJE Allergan
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date March 2013

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