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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01177098
First received: August 4, 2010
Last updated: March 22, 2013
Last verified: March 2013

August 4, 2010
March 22, 2013
October 2010
February 2012   (final data collection date for primary outcome measure)
  • Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Intraocular Pressure [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01177098 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).
Not Provided
Not Provided
Not Provided
 
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
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Glaucoma
  • Ocular Hypertension
  • 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®
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
561
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Czech Republic,   Germany,   Hungary,   Israel,   Russian Federation,   Spain,   United Kingdom
 
NCT01177098
192024-050, 2010-021507-24
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
March 2013

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