Safety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01547598
• Collaborator: (none)
• Enrollment: 135
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 7.1

Study Details

Study Description

Brief Summary

This non-inferiority study will assess safety and efficacy of LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) versus DuoTrav® (travoprost 0.004%/timolol 0.5% combination ophthalmic solution) in patients previously on Travatan® Z (travoprost ophthalmic solution 0.004%) monotherapy.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-Angle; Ocular Hypertension	Drug: travoprost ophthalmic solution 0.004%; Drug: travoprost 0.004% / timolol 0.5% combination ophthalmic solution; Drug: Bimatoprost ophthalmic solution 0.01%	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 135 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: LUMIGAN® RC Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.	Drug: travoprost ophthalmic solution 0.004%; Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks.; Other Names: Travatan® Z ; Drug: Bimatoprost ophthalmic solution 0.01%; LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.; Other Names: LUMIGAN® RC
Active Comparator: DuoTrav® Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.	Drug: travoprost ophthalmic solution 0.004%; Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks.; Other Names: Travatan® Z ; Drug: travoprost 0.004% / timolol 0.5% combination ophthalmic solution; DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.; Other Names: DuoTrav®

Outcome Measures

Primary Outcome Measures

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

   IOP is a measurement of the fluid pressure inside the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each study eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.

Secondary Outcome Measures

1. Change From Baseline in Mean IOP at Week 12 [Baseline, Week 12]

   IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 12. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.

2. Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline [Baseline, Week 12]

   IOP is a measurement of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.

3. Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg [Week 12]

   IOP is a measure of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.

4. Change From Baseline in Mean IOP at Week 6 [Baseline, Week 6]

   IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 6. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Open angle glaucoma or ocular hypertension

• Best corrected visual acuity of 20/100 or better in both eyes

Exclusion Criteria:

• Ocular surgery within 3 months, or anticipated ocular surgery within 12 weeks

• Previous treatment with LUMIGAN® RC or DuoTrav®

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

• Active ocular inflammation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Vancouver	British Columbia	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: NCT01547598
• Other Study ID Numbers: GMA-LUM-11-020
• First Posted: Mar 8, 2012
• Last Update Posted: Aug 15, 2014
• Last Verified: Jul 1, 2014

• Additional relevant MeSH terms: Ocular Hypertension; Glaucoma, Open-Angle; Timolol; Bimatoprost; Travoprost; Pharmaceutical Solutions; Ophthalmic Solutions

Study Results

Participant Flow

Arm/Group Title	LUMIGAN® RC	DuoTrav®
Arm/Group Description	Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.	Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
Period Title: Overall Study
STARTED	67	68
COMPLETED	61	63
NOT COMPLETED	6	5

Baseline Characteristics

Arm/Group Title	LUMIGAN® RC	DuoTrav®	Total
Arm/Group Description	Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.	Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.	Total of all reporting groups
Overall Participants	67	68	135
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	67.2 (9.7)	65.2 (10.7)	66.2 (10.3)
Sex: Female, Male (Count of Participants)
Female	40 59.7%	40 58.8%	80 59.3%
Male	27 40.3%	28 41.2%	55 40.7%

Outcome Measures

1. Primary Outcome

Title	Mean Diurnal Intraocular Pressure (IOP)
Description	IOP is a measurement of the fluid pressure inside the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each study eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Participants from the modified Intent-to-treat (mITT) population, all randomized participants who received at least one dose of study treatment and met inclusion criteria, with data available for analysis.

Arm/Group Title	LUMIGAN® RC	DuoTrav®
Arm/Group Description	Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.	Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
Measure Participants	61	63
Mean (Standard Deviation) [mmHg]	18.6 (3.5)	17.4 (2.7)

2. Secondary Outcome

Title	Change From Baseline in Mean IOP at Week 12
Description	IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 12. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Participants from the Full Analysis Set IOP population, all randomized participants who received at least one dose of study treatment and met study inclusion criteria, with IOP data available for analysis at the given time-point.

Arm/Group Title	LUMIGAN® RC	DuoTrav®
Arm/Group Description	Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.	Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
Measure Participants	66	68
Baseline_8 AM	22.0 (2.9)	22.0 (4.1)
Change from Baseline at Week 12 _8 AM (n=61,63)	-2.7 (3.4)	-4.5 (3.1)
Baseline_12 Noon	20.6 (3.2)	20.3 (3.8)
Change from Baseline at Week 12_12 Noon (n=61,63)	-1.9 (3.1)	-2.3 (3.2)
Baseline_4 PM	19.8 (3.1)	19.8 (4.1)
Change from Baseline at Week 12_4 PM (n=61,63)	-1.3 (2.7)	-2.4 (3.5)

3. Secondary Outcome

Title	Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline
Description	IOP is a measurement of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Participants from the mITT population, all randomized participants who received at least one dose of study treatment and met inclusion criteria, with data available for analysis.

Arm/Group Title	LUMIGAN® RC	DuoTrav®
Arm/Group Description	Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.	Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
Measure Participants	61	63
Number [percentage of participants]	26.2 39.1%	47.6 70%

4. Secondary Outcome

Title	Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg
Description	IOP is a measure of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Participants from the mITT population, all randomized participants who received at least one dose of study treatment and met inclusion criteria, with data available for analysis.

Arm/Group Title	LUMIGAN® RC	DuoTrav®
Arm/Group Description	Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.	Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
Measure Participants	61	63
Number [percentage of participants]	11.5 17.2%	17.5 25.7%

5. Secondary Outcome

Title	Change From Baseline in Mean IOP at Week 6
Description	IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 6. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.
Time Frame	Baseline, Week 6

Outcome Measure Data

Analysis Population Description

Participants from the Full Analysis Set IOP population, all randomized participants who received at least one dose of study treatment and met study inclusion criteria, with IOP data available for analysis at the given time-point.

Arm/Group Title	LUMIGAN® RC	DuoTrav®
Arm/Group Description	Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.	Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
Measure Participants	66	68
Baseline_ 8 AM	22.0 (2.9)	22.0 (4.1)
Change from Baseline at Week 6 _8 AM (n=66,64)	-2.8 (2.9)	-4.8 (4.1)
Baseline_12 Noon	20.6 (3.2)	20.3 (3.8)
Change from Baseline at Week 6_12 Noon (n=66,64)	-2.1 (3.1)	-2.8 (3.4)
Baseline_4 PM	19.8 (3.1)	19.8 (4.1)
Change from Baseline at Week 6_4 PM (n=66,64)	-1.5 (2.5)	-2.9 (3.6)

Adverse Events

Arm/Group Title	Travatan® Z		LUMIGAN® RC		DuoTrav®
Arm/Group Description	Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks for all participants.		Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.		Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
All Cause Mortality
	Travatan® Z		LUMIGAN® RC		DuoTrav®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Travatan® Z		LUMIGAN® RC		DuoTrav®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/135 (0%)		0/67 (0%)		1/68 (1.5%)
General disorders
Pyrexia	0/135 (0%)		0/67 (0%)		1/68 (1.5%)
Infections and infestations
Cellulitis	0/135 (0%)		0/67 (0%)		1/68 (1.5%)
Other (Not Including Serious) Adverse Events
	Travatan® Z		LUMIGAN® RC		DuoTrav®
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/135 (0%)		0/67 (0%)		0/68 (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.