Trial Outcomes & Findings for Safety and Efficacy of Bimatoprost Timolol Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension (NCT NCT01068964)

Results Overview

The difference of change from baseline of mean diurnal IOP between the 0.03% Bimatoprost/0.5% Timolol in Same Bottle and the 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles at week 4. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of the study eye (the eye with the highest IOP at baseline) over the 3 time points measured at 8AM, 12PM and 4PM. A negative number change from baseline indicated a reduction (improvement) in IOP. The difference of change from baseline in IOP is presented in the statistical analysis section.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

235 participants

Primary outcome timeframe

Baseline, Week 4

Results posted on

2019-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	0.03% Bimatoprost/0.5% Timolol in Same Bottle Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution	0.03% Bimatoprost and 0.5% Timolol in Separate Bottles Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
Overall Study STARTED	121	114
Overall Study COMPLETED	113	104
Overall Study NOT COMPLETED	8	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Bimatoprost Timolol Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.03% Bimatoprost/0.5% Timolol in Same Bottle n=121 Participants Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution	0.03% Bimatoprost and 0.5% Timolol in Separate Bottles n=114 Participants Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution	Total n=235 Participants Total of all reporting groups
Age, Continuous	45.73 years STANDARD_DEVIATION 14.77 • n=5 Participants	44.28 years STANDARD_DEVIATION 16.28 • n=7 Participants	45.02 years STANDARD_DEVIATION 15.51 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	46 Participants n=7 Participants	92 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants	68 Participants n=7 Participants	143 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: Intent to Treatment population defined as all patients randomized. One patient in the 0.03% Bimatoprost/0.5% Timolol in Same Bottle group was not included in the analysis.

The difference of change from baseline of mean diurnal IOP between the 0.03% Bimatoprost/0.5% Timolol in Same Bottle and the 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles at week 4. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of the study eye (the eye with the highest IOP at baseline) over the 3 time points measured at 8AM, 12PM and 4PM. A negative number change from baseline indicated a reduction (improvement) in IOP. The difference of change from baseline in IOP is presented in the statistical analysis section.

Outcome measures

Outcome measures
Measure	0.03% Bimatoprost/0.5% Timolol in Same Bottle n=120 Participants Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution	0.03% Bimatoprost and 0.5% Timolol in Separate Bottles n=114 Participants Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4 Baseline	25.20 Millimeters of mercury (mmHg) Standard Deviation 3.06	24.87 Millimeters of mercury (mmHg) Standard Deviation 3.88
The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4 Change from Baseline at Week 4	-9.38 Millimeters of mercury (mmHg) Standard Deviation 4.66	-8.93 Millimeters of mercury (mmHg) Standard Deviation 4.25

Adverse Events

0.03% Bimatoprost/0.5% Timolol in Same Bottle

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

0.03% Bimatoprost and 0.5% Timolol in Separate Bottles

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	0.03% Bimatoprost/0.5% Timolol in Same Bottle n=121 participants at risk Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution	0.03% Bimatoprost and 0.5% Timolol in Separate Bottles n=114 participants at risk Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
Endocrine disorders Goitre	0.00% 0/121	0.88% 1/114
Eye disorders Ocular hypertension	0.00% 0/121	0.88% 1/114

Other adverse events

Other adverse events
Measure	0.03% Bimatoprost/0.5% Timolol in Same Bottle n=121 participants at risk Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution	0.03% Bimatoprost and 0.5% Timolol in Separate Bottles n=114 participants at risk Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
Eye disorders Conjunctival hyperaemia	21.5% 26/121	18.4% 21/114
Eye disorders Eye pain	3.3% 4/121	7.0% 8/114

Additional Information

Therapeutic Area Head

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