An Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01881126
• Collaborator: (none)
• Enrollment: 93
• Locations: 2
• Arms: 2
• Duration (Months): 16
• Patients Per Site: 46.5
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

This efficacy and safety study will evaluate LUMIGAN® RC/ LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL MALEATE-EX, 0.5%/TIMOLOL GFS 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Ocular Hypertension	Drug: bimatoprost 0.01%; Drug: travatan 0.004%; Drug: timolol 0.5%; Drug: hypromellose 0.3%	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 93 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: bimatoprost 0.01% and hypromellose 0.3% Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.	Drug: bimatoprost 0.01%; Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.; Other Names: Lumigan® RC Lumigan® ; Drug: hypromellose 0.3%; Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.; Other Names: GenTeal®
Active Comparator: travatan 0.004% and timolol 0.5% Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.	Drug: travatan 0.004%; Travatan 0.004% administered to both eyes once daily for 12 weeks.; Other Names: Travatan Z® ; Drug: timolol 0.5%; Timolol 0.5% administered to both eyes once daily for 12 weeks.; Other Names: Timolol Maleate-EX Timolol GFS

Outcome Measures

Primary Outcome Measures

1. Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM [Week 12 at 8 AM, 12 PM, and 4 PM]

   IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Ocular hypertension or glaucoma that requires treatment with medication

• Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes

Exclusion Criteria:

• History of LASIK, LASEK, RK, and/or PRK in the study eye(s)

• History of any intraocular surgery or glaucoma laser surgery in the study eye(s) within 3 months

• Use of topical, periorbital, intravitreal or systemic steroid within 3 months or expected use during the course of study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Barrie	Ontario	Canada
2		Toronto	Ontario	Canada

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: NCT01881126
• Other Study ID Numbers: GMA-LUM-12-021
• First Posted: Jun 19, 2013
• Last Update Posted: Nov 30, 2015
• Last Verified: Oct 1, 2015

• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Hypertension; Timolol; Bimatoprost; Travoprost

Study Results

Participant Flow

Arm/Group Title	Bimatoprost 0.01% and Hypromellose 0.3%	Travatan 0.004% and Timolol 0.5%
Arm/Group Description	Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.	Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
Period Title: Overall Study
STARTED	47	46
COMPLETED	46	44
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Bimatoprost 0.01% and Hypromellose 0.3%	Travatan 0.004% and Timolol 0.5%	Total
Arm/Group Description	Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.	Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.	Total of all reporting groups
Overall Participants	47	46	93
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	67.8 (9.34)	67.3 (8.19)	67.5 (8.74)
Sex: Female, Male (Count of Participants)
Female	24 51.1%	18 39.1%	42 45.2%
Male	23 48.9%	28 60.9%	51 54.8%

Outcome Measures

1. Primary Outcome

Title	Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM
Description	IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements.
Time Frame	Week 12 at 8 AM, 12 PM, and 4 PM

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: all subjects who were randomized to study medication

Arm/Group Title	Bimatoprost 0.01% and Hypromellose 0.3%	Travatan 0.004% and Timolol 0.5%
Arm/Group Description	Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.	Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
Measure Participants	46	44
Week 12 at 8 AM	16.4 (0.46)	15.1 (0.43)
Week 12 at 12 PM	16.0 (0.49)	15.0 (0.38)
Week 12 at 4 PM	16.5 (0.48)	14.5 (0.34)

Adverse Events

Arm/Group Title	Bimatoprost 0.01% and Hypromellose 0.3%		Travatan 0.004% and Timolol 0.5%
Arm/Group Description	Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.		Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
All Cause Mortality
	Bimatoprost 0.01% and Hypromellose 0.3%		Travatan 0.004% and Timolol 0.5%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bimatoprost 0.01% and Hypromellose 0.3%		Travatan 0.004% and Timolol 0.5%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/47 (2.1%)		0/46 (0%)
Cardiac disorders
Angina Pain	1/47 (2.1%)		0/46 (0%)
Myocardial Infarction	1/47 (2.1%)		0/46 (0%)
Other (Not Including Serious) Adverse Events
	Bimatoprost 0.01% and Hypromellose 0.3%		Travatan 0.004% and Timolol 0.5%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/47 (0%)		0/46 (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.