Trial Outcomes & Findings for 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 (NCT NCT01881126)

NCT ID: NCT01881126

Last Updated: 2015-11-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 93 participants
• Primary outcome timeframe: Week 12 at 8 AM, 12 PM, and 4 PM
• Results posted on: 2015-11-30

Participant Flow

Participant milestones

Measure	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.	Travatan 0.004% and Timolol 0.5% Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
Overall Study STARTED	47	46
Overall Study COMPLETED	46	44
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	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.	Travatan 0.004% and Timolol 0.5% Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
Overall Study Non-compliance	1	1
Overall Study Adverse Event	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Bimatoprost 0.01% and Hypromellose 0.3% n=47 Participants 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% n=46 Participants Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.	Total n=93 Participants Total of all reporting groups
Age, Continuous	67.8 Years STANDARD_DEVIATION 9.34 • n=5 Participants	67.3 Years STANDARD_DEVIATION 8.19 • n=7 Participants	67.5 Years STANDARD_DEVIATION 8.74 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	18 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	28 Participants n=7 Participants	51 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12 at 8 AM, 12 PM, and 4 PM

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

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.

Outcome measures

Measure	Bimatoprost 0.01% and Hypromellose 0.3% n=46 Participants 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% n=44 Participants Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM Week 12 at 8 AM	16.4 Millimeters of Mercury (mmHg) Standard Deviation 0.46	15.1 Millimeters of Mercury (mmHg) Standard Deviation 0.43
Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM Week 12 at 12 PM	16.0 Millimeters of Mercury (mmHg) Standard Deviation 0.49	15.0 Millimeters of Mercury (mmHg) Standard Deviation 0.38
Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM Week 12 at 4 PM	16.5 Millimeters of Mercury (mmHg) Standard Deviation 0.48	14.5 Millimeters of Mercury (mmHg) Standard Deviation 0.34

Adverse Events

Bimatoprost 0.01% and Hypromellose 0.3%

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Travatan 0.004% and Timolol 0.5%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bimatoprost 0.01% and Hypromellose 0.3% n=47 participants at risk 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% n=46 participants at risk Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
Cardiac disorders Angina Pain	2.1% 1/47	0.00% 0/46
Cardiac disorders Myocardial Infarction	2.1% 1/47	0.00% 0/46

Other adverse events

Adverse event data not reported

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: clinicaltrials@allergan.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER