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

Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01177098
• Other study ID #: 192024-050
• Secondary ID: 2010-021507-24
• Status: Completed
• Phase: Phase 3
• First received: August 4, 2010
• Last updated: March 22, 2013
• Start date: October 2010
• Est. completion date: February 2012

Study information

• Verified date: March 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 561
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia,  Czech Republic,  Germany,  Hungary,  Israel,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at 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).	Baseline, Week 12	No
Primary	Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at 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.	Week 2	No
Primary	Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at 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.	Week 6	No
Primary	Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at 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.	Week 12	No
Secondary	Change From Baseline in Worse Eye IOP at Each Hour Evaluated at 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).	Baseline, Week 12	No
Secondary	Change From Baseline in Average Eye IOP at Each Hour Evaluated at 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).	Baseline, Week 12	No