Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00735449
• Collaborator: (none)
• Enrollment: 204
• Locations: 2
• Arms: 2
• Duration (Months): 17
• Patients Per Site: 102
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive therapy to Xalatan in subjects with glaucoma or ocular hypertension.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Ocular Hypertension	Drug: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%; Drug: timolol maleate 0.5%; Drug: latanoprost 0.005%	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 204 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Combigan ® Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%) adjunctive to Xalatan® (latanoprost 0.005%)	Drug: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%; 1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.; Other Names: Combigan® ; Drug: latanoprost 0.005%; 1 drop of latanoprost 0.005% once nightly.; Other Names: Xalatan®
Active Comparator: Timolol Maleate 0.5% Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)	Drug: timolol maleate 0.5%; 1 drop of timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.; Other Names: Timpoptic® Timoptol® ; Drug: latanoprost 0.005%; 1 drop of latanoprost 0.005% once nightly.; Other Names: Xalatan®

Outcome Measures

Primary Outcome Measures

1. Mean Intraocular Pressure (IOP) at 10 AM at Week 12 [Week 12]

   Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye.

Secondary Outcome Measures

1. Mean Intraocular Pressure (IOP) at 10 AM at Week 6 [Week 6]

   Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.

2. Mean Intraocular Pressure (IOP) at 8 AM at Week 12 [Week 12]

   Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye.

3. Mean Intraocular Pressure (IOP) at 8 AM at Week 6 [Week 6]

   Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.

4. Number of Subjects With Adverse Events [Week 12]

   Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Be at least 18 years of age

• Give written informed consent

• Be in good general health as determined by your doctor

• Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension

• If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills)

• Understand the study instructions, and be able to follow the study instructions; and

• Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits

Exclusion Criteria:

• Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation

• History of severe renal or hepatic impairment

• Subjects with severe cardiovascular disease should not be enrolled unless their disease is controlled and clearance has been obtained from the subject's primary care physician and/or cardiologist

• Contraindications to beta-adrenoceptor antagonist therapy such as chronic obstructive pulmonary disease, bronchial asthma, sinus bradycardia, second and third degree atrioventricular block, overt cardiac failure and cardiogenic shock or uncontrolled congestive heart failure

• Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and

• Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the screening visit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Newark	New Jersey	United States
2		Montreal	Quebec	Canada

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

• Fechtner RD, Harasymowycz P, Nixon DR, Vold SD, Zaman F, Williams JM, Hollander DA. Twelve-week, randomized, multicenter study comparing a fixed combination of brimonidine-timolol with timolol as therapy adjunctive to latanoprost. Clin Ophthalmol. 2011;5:945-53. doi: 10.2147/OPTH.S19999. Epub 2011 Jul 8.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT00735449
• Other Study ID Numbers: GMA-COM-07-XTC
• First Posted: Aug 15, 2008
• Last Update Posted: Apr 23, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Hypertension; Timolol; Brimonidine Tartrate; Latanoprost; Maleic acid

Study Results

Participant Flow

Arm/Group Title	Combigan®	Timolol Maleate 0.5%
Arm/Group Description	Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)	Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
Period Title: Overall Study
STARTED	102	102
COMPLETED	95	96
NOT COMPLETED	7	6

Baseline Characteristics

Arm/Group Title	Combigan®	Timolol Maleate 0.5%	Total
Arm/Group Description	Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)	Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)	Total of all reporting groups
Overall Participants	102	102	204
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	64.5	65.9	65.4
Sex: Female, Male (Count of Participants)
Female	57 55.9%	45 44.1%	102 50%
Male	45 44.1%	57 55.9%	102 50%

Outcome Measures

1. Secondary Outcome

Title	Mean Intraocular Pressure (IOP) at 10 AM at Week 6
Description	Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit.

Arm/Group Title	Combigan®	Timolol Maleate 0.5%
Arm/Group Description	Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)	Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
Measure Participants	98	97
Mean (Standard Deviation) [Millimeters of mercury (mmHg)]	15.9 (3.10)	16.7 (2.78)

2. Primary Outcome

Title	Mean Intraocular Pressure (IOP) at 10 AM at Week 12
Description	Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit and who were assessed for this outcome measure at the Week 12 visit.

Arm/Group Title	Combigan®	Timolol Maleate 0.5%
Arm/Group Description	Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)	Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
Measure Participants	94	94
Mean (Standard Deviation) [Millimeters of mercury (mmHg)]	15.1 (2.59)	16.9 (2.46)

3. Secondary Outcome

Title	Mean Intraocular Pressure (IOP) at 8 AM at Week 12
Description	Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit and who were assessed for this outcome measure at the Week 12 visit.

Arm/Group Title	Combigan®	Timolol Maleate 0.5%
Arm/Group Description	Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)	Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
Measure Participants	96	94
Mean (Standard Deviation) [Millimeters of mercury (mmHg)]	17.0 (2.55)	17.7 (2.58)

4. Secondary Outcome

Title	Mean Intraocular Pressure (IOP) at 8 AM at Week 6
Description	Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.
Time Frame	Week 6

Outcome Measure Data

Analysis Population Description

Per-protocol, which included all patients who started the study (randomized) and had at least one follow-up visit.

Arm/Group Title	Combigan®	Timolol Maleate 0.5%
Arm/Group Description	Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)	Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
Measure Participants	98	97
Mean (Standard Deviation) [Millimeters of mercury (mmHg)]	17.3 (2.87)	17.8 (3.17)

5. Secondary Outcome

Title	Number of Subjects With Adverse Events
Description	Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit).
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Safety population, which included all patients who started the study (randomized) and were treated.

Arm/Group Title	Combigan®	Timolol Maleate 0.5%
Arm/Group Description	Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)	Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
Measure Participants	102	102
Number [Participants]	15 14.7%	13 12.7%

Adverse Events

Arm/Group Title	Combigan®		Timolol Maleate 0.5%
Arm/Group Description	Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%)adjunctive to Xalatan® (latanoprost 0.005%)		Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%)
All Cause Mortality
	Combigan®		Timolol Maleate 0.5%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Combigan®		Timolol Maleate 0.5%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/102 (0%)		2/102 (2%)
Infections and infestations
Bacterial bronchitis	0/102 (0%)		1/102 (1%)
Respiratory, thoracic and mediastinal disorders
Acute exacerbation of COPD	0/102 (0%)		1/102 (1%)
Other (Not Including Serious) Adverse Events
	Combigan®		Timolol Maleate 0.5%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/102 (0%)		0/102 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo