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

• 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: Allergan
• Information provided by (Responsible Party): Allergan

Tracking Information

• First Submitted Date: August 4, 2010
• First Posted Date: August 6, 2010
• Results First Submitted Date: February 7, 2013
• Results First Posted Date: March 12, 2013
• Last Update Posted Date: March 29, 2013
• Study Start Date: October 2010
• Actual Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: August 5, 2010): Intraocular Pressure [ Time Frame: Week 12 ]

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Glaucoma
• Ocular Hypertension

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 27, 2012): 561
• Original Estimated Enrollment (submitted: August 5, 2010): 500
• Actual Study Completion Date: February 2012
• Actual Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Czech Republic, Germany, Hungary, Israel, Russian Federation, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT01177098
• Other Study ID Numbers: 192024-050; 2010-021507-24 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Allergan
• Original Responsible Party: Therapeutic Area Head, Allergan, Inc.
• Current Study Sponsor: Allergan
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Allergan

• PRS Account: Allergan
• Verification Date: March 2013