Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01229462
• Collaborator: (none)
• Enrollment: 238
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 21.6

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in patients with glaucoma or ocular hypertension who do not respond well to topical beta blockers.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Ocular Hypertension	Drug: brimonidine tartrate/timolol fixed combination ophthalmic solution; Drug: brimonidine tartrate ophthalmic solution; Drug: timolol ophthalmic solution; Other: fixed combination vehicle	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 238 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Combigan® One drop of brimonidine tartrate/timolol combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.	Drug: brimonidine tartrate/timolol fixed combination ophthalmic solution; One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.; Other Names: Combigan® ; Other: fixed combination vehicle; Fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Active Comparator: Alphagan® and Timolol Concurrent One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.	Drug: brimonidine tartrate ophthalmic solution; One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.; Other Names: Alphagan® ; Drug: timolol ophthalmic solution; One drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4 [Baseline, Week 4]

   Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Open-angle glaucoma or ocular hypertension in at least one eye that is not responsive to topical beta blockers

• No anticipated wearing of contact lenses during study

Exclusion Criteria:

• Active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye)

• Any intraocular surgery or laser (eg, cataract surgery or Lasik) within 3 months

• Required regular use of other ocular medications except for occasional use of artificial tears

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Guangzhou	Guangdong	China

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01229462
• Other Study ID Numbers: 190342-035
• First Posted: Oct 27, 2010
• Last Update Posted: Sep 14, 2012
• Last Verified: Aug 1, 2012

• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Hypertension; Timolol; Brimonidine Tartrate; Pharmaceutical Solutions; Ophthalmic Solutions

Study Results

Participant Flow

Arm/Group Title	Combigan®	Alphagan® and Timolol Concurrent
Arm/Group Description	One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.	One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Period Title: Overall Study
STARTED	120	118
COMPLETED	115	109
NOT COMPLETED	5	9

Baseline Characteristics

Arm/Group Title	Combigan®	Alphagan® and Timolol Concurrent	Total
Arm/Group Description	One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.	One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.	Total of all reporting groups
Overall Participants	120	118	238
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	46.2 (15.18)	48.2 (15.57)	47.2 (15.38)
Sex: Female, Male (Count of Participants)
Female	48 40%	55 46.6%	103 43.3%
Male	72 60%	63 53.4%	135 56.7%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4
Description	Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).
Time Frame	Baseline, Week 4

Outcome Measure Data

Analysis Population Description

Intent-to-treat population consisted of all randomized participants.

Arm/Group Title	Combigan®	Alphagan® and Timolol Concurrent
Arm/Group Description	One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.	One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Measure Participants	120	118
Baseline	25.07 (3.737)	24.53 (2.926)
Change from baseline at Week 4	-6.21 (3.550)	-5.70 (3.469)

Adverse Events

Adverse Event Reporting Description	Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
Arm/Group Title	Combigan®		Alphagan® and Timolol Concurrent
Arm/Group Description	One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.		One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
All Cause Mortality
	Combigan®		Alphagan® and Timolol Concurrent
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Combigan®		Alphagan® and Timolol Concurrent
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/120 (0.8%)		1/116 (0.9%)
Ear and labyrinth disorders
Sudden hearing loss	1/120 (0.8%)		0/116 (0%)
Nervous system disorders
VIth nerve paralysis	0/120 (0%)		1/116 (0.9%)
Other (Not Including Serious) Adverse Events
	Combigan®		Alphagan® and Timolol Concurrent
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/120 (0%)		0/116 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.