Comparing Safety and Efficacy of Combigan® and Lumigan® With Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated With Xalatan®

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01170884
• Collaborator: (none)
• Enrollment: 121
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 13.4

Study Details

Study Description

Brief Summary

Comparing Safety and Efficacy of Combigan® and Lumigan® with Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated with Xalatan®.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Ocular Hypertension	Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; bimatoprost 0.03% ophthalmic solution; Drug: bimatoprost 0.03% ophthalmic solution; hypromellose 0.2% eyedrops	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 121 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Combigan® + Lumigan® COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)	Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; bimatoprost 0.03% ophthalmic solution; 1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution (Combigan®) taken approximately 12 hours apart, up to 2 times a day and 1 drop of bimatoprost 0.03% ophthalmic solution (Lumigan®) taken once every 24 hours.; Other Names: COMBIGAN® LUMIGAN®
Active Comparator: Lumigan® LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes	Drug: bimatoprost 0.03% ophthalmic solution; hypromellose 0.2% eyedrops; 1 drop of bimatoprost 0.03% ophthalmic solution (Lumigan®) taken approximately every 24 hours; mild lubricant eyedrops (Gen Teal® Mild) for masking purposes; Other Names: LUMIGAN® Gen Teal® Mild

Outcome Measures

Primary Outcome Measures

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

   Mean Diurnal (average of 8 AM, 10 AM, and 4 PM time points) IOP at Week 12 in the study eye. IOP is a measurement of the fluid pressure inside the eye.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Diagnosed with glaucoma or ocular hypertension.

• Visual Acuity 20/100 or better in both eyes

Exclusion Criteria:

• Any active ocular disease

• History of any intraocular surgery or glaucoma laser surgery within 3 months

• Contraindication to pupil dilation

• Use of topical, periorbital, intravitreal, or systemic steroid within 3 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Dallas	Texas	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

• Myers JS, Vold S, Zaman F, Williams JM, Hollander DA. Bimatoprost 0.01% or 0.03% in patients with glaucoma or ocular hypertension previously treated with latanoprost: two randomized 12-week trials. Clin Ophthalmol. 2014 Mar 27;8:643-52. doi: 10.2147/OPTH.S59197. eCollection 2014.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01170884
• Other Study ID Numbers: GMA-COM-09-013
• First Posted: Jul 27, 2010
• Last Update Posted: Apr 24, 2019
• Last Verified: Apr 1, 2019

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

Study Results

Participant Flow

Arm/Group Title	Combigan® + Lumigan®	Lumigan®
Arm/Group Description	COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)	LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
Period Title: Overall Study
STARTED	59	62
COMPLETED	54	60
NOT COMPLETED	5	2

Baseline Characteristics

Arm/Group Title	Combigan® + Lumigan®	Lumigan®	Total
Arm/Group Description	COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)	LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes	Total of all reporting groups
Overall Participants	59	62	121
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.0 (10.52)	62.6 (13.19)	63.3 (11.93)
Sex: Female, Male (Count of Participants)
Female	28 47.5%	36 58.1%	64 52.9%
Male	31 52.5%	26 41.9%	57 47.1%

Outcome Measures

1. Primary Outcome

Title	Mean Diurnal Intraocular Pressure (IOP) at Week 12
Description	Mean Diurnal (average of 8 AM, 10 AM, and 4 PM time points) IOP at Week 12 in the study eye. IOP is a measurement of the fluid pressure inside the eye.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) included all subjects who were randomized to study medication.

Arm/Group Title	Combigan® + Lumigan®	Lumigan®
Arm/Group Description	COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)	LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
Measure Participants	59	62
Mean (Standard Deviation) [Millimeters of mercury (mm Hg)]	15.4 (2.34)	19.2 (3.42)

Adverse Events

Arm/Group Title	Combigan® + Lumigan®		Lumigan®
Arm/Group Description	COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)		LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
All Cause Mortality
	Combigan® + Lumigan®		Lumigan®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Combigan® + Lumigan®		Lumigan®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/62 (0%)
Other (Not Including Serious) Adverse Events
	Combigan® + Lumigan®		Lumigan®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/59 (16.9%)		1/62 (1.6%)
Eye disorders
Foreign Body Sensation	3/59 (5.1%)		0/62 (0%)
Ocular Redness	7/59 (11.9%)		1/62 (1.6%)

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