Trial Outcomes & Findings for 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 NCT02097719)

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

100 participants

Primary outcome timeframe

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

Results posted on

2016-01-14

Participant Flow

Participant milestones

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.	Travoprost 0.004% and Timolol 0.5% Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
Overall Study STARTED	49	51
Overall Study COMPLETED	46	50
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

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.	Travoprost 0.004% and Timolol 0.5% Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
Overall Study Subject Withdrew Consent	1	0
Overall Study Lost to Follow-up	0	1
Overall Study Adverse Event	2	0

Baseline Characteristics

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

Baseline characteristics by cohort
Measure	Bimatoprost 0.01% and Hypromellose 0.3% n=49 Participants Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.	Travoprost 0.004% and Timolol 0.5% n=51 Participants Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.	Total n=100 Participants Total of all reporting groups
Age, Continuous	63.5 Years STANDARD_DEVIATION 11.73 • n=5 Participants	65.5 Years STANDARD_DEVIATION 9.98 • n=7 Participants	64.5 Years STANDARD_DEVIATION 10.86 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	20 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	31 Participants n=7 Participants	54 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 with data at the noted time point

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

Outcome measures
Measure	Bimatoprost 0.01% and Hypromellose 0.3% n=49 Participants Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.	Travoprost 0.004% and Timolol 0.5% n=51 Participants Travoprost 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 12 PM (N=46, 50)	16.2 Millimeters of Mercury (mmHg) Standard Deviation 0.43	15.6 Millimeters of Mercury (mmHg) Standard Deviation 0.54
Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM Week 12 at 4 PM (N=47, 50)	16.0 Millimeters of Mercury (mmHg) Standard Deviation 0.46	15.4 Millimeters of Mercury (mmHg) Standard Deviation 0.60
Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM Week 12 at 8 AM (N=46, 50)	16.7 Millimeters of Mercury (mmHg) Standard Deviation 0.50	15.4 Millimeters of Mercury (mmHg) Standard Deviation 0.48

Adverse Events

Bimatoprost 0.01% and Hypromellose 0.3%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Travoprost 0.004% and Timolol 0.5%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

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