Trial Outcomes & Findings for A Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic Glaucoma or Ocular Hypertension (NCT NCT01863953)

Last Updated: 2015-01-26

Results Overview

IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

112 participants

Primary outcome timeframe

Baseline, Day 42

Results posted on

2015-01-26

Participant Flow

Participant milestones

Participant milestones
Measure	Fixed-Combination Bimatoprost/Brimonidine One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.	Bimatoprost Ophthalmic Solution 0.01% and Vehicle One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.	Brimonidine Tartrate Ophthalmic Solution 0.2% One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Overall Study STARTED	38	36	38
Overall Study COMPLETED	38	36	37
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Fixed-Combination Bimatoprost/Brimonidine One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.	Bimatoprost Ophthalmic Solution 0.01% and Vehicle One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.	Brimonidine Tartrate Ophthalmic Solution 0.2% One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Overall Study Adverse Event	0	0	1

Baseline Characteristics

A Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic Glaucoma or Ocular Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fixed-Combination Bimatoprost/Brimonidine n=38 Participants One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.	Bimatoprost Ophthalmic Solution 0.01% and Vehicle n=36 Participants One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.	Brimonidine Tartrate Ophthalmic Solution 0.2% n=38 Participants One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.	Total n=112 Participants Total of all reporting groups
Age, Customized <45 years	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Age, Customized Between 45 and 65 years	21 Participants n=5 Participants	14 Participants n=7 Participants	20 Participants n=5 Participants	55 Participants n=4 Participants
Age, Customized >65 years	16 Participants n=5 Participants	22 Participants n=7 Participants	18 Participants n=5 Participants	56 Participants n=4 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	22 Participants n=7 Participants	25 Participants n=5 Participants	67 Participants n=4 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	14 Participants n=7 Participants	13 Participants n=5 Participants	45 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Day 42

Population: Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment

Outcome measures

Outcome measures
Measure	Fixed-Combination Bimatoprost/Brimonidine n=38 Participants One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.	Bimatoprost Ophthalmic Solution 0.01% and Vehicle n=36 Participants One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.	Brimonidine Tartrate Ophthalmic Solution 0.2% n=38 Participants One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP) Baseline	24.54 Millimeters of Mercury (mmHg) Standard Deviation 1.712	24.38 Millimeters of Mercury (mmHg) Standard Deviation 2.022	24.29 Millimeters of Mercury (mmHg) Standard Deviation 1.457
Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP) Change from Baseline at Day 42 (N=38, 36, 37)	-6.79 Millimeters of Mercury (mmHg) Standard Deviation 2.277	-6.63 Millimeters of Mercury (mmHg) Standard Deviation 2.284	-3.92 Millimeters of Mercury (mmHg) Standard Deviation 2.574

SECONDARY outcome

Timeframe: Baseline, Day 14, Day 28

Population: Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment

Outcome measures

Outcome measures
Measure	Fixed-Combination Bimatoprost/Brimonidine n=38 Participants One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.	Bimatoprost Ophthalmic Solution 0.01% and Vehicle n=36 Participants One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.	Brimonidine Tartrate Ophthalmic Solution 0.2% n=38 Participants One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Change From Baseline in Average Eye Mean Diurnal IOP Baseline	24.54 mmHg Standard Deviation 1.712	24.38 mmHg Standard Deviation 2.022	24.29 mmHg Standard Deviation 1.457
Change From Baseline in Average Eye Mean Diurnal IOP Change from Baseline at Day 14	-7.63 mmHg Standard Deviation 2.152	-6.79 mmHg Standard Deviation 1.997	-4.67 mmHg Standard Deviation 2.944
Change From Baseline in Average Eye Mean Diurnal IOP Change from Baseline at Day 28	-7.25 mmHg Standard Deviation 2.328	-6.98 mmHg Standard Deviation 2.260	-4.22 mmHg Standard Deviation 2.869

SECONDARY outcome

Timeframe: Day 14, Day 28, Day 42

Population: Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment

IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12.

Outcome measures

Outcome measures
Measure	Fixed-Combination Bimatoprost/Brimonidine n=38 Participants One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.	Bimatoprost Ophthalmic Solution 0.01% and Vehicle n=36 Participants One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.	Brimonidine Tartrate Ophthalmic Solution 0.2% n=38 Participants One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Average Eye Mean Diurnal IOP Day 14	16.91 mmHg Standard Deviation 2.004	17.59 mmHg Standard Deviation 2.363	19.61 mmHg Standard Deviation 2.572
Average Eye Mean Diurnal IOP Day 28	17.29 mmHg Standard Deviation 2.588	17.40 mmHg Standard Deviation 2.549	20.06 mmHg Standard Deviation 2.540
Average Eye Mean Diurnal IOP Day 42 (N=38, 36, 37)	17.75 mmHg Standard Deviation 2.505	17.76 mmHg Standard Deviation 2.467	20.34 mmHg Standard Deviation 2.218

Adverse Events

Fixed-Combination Bimatoprost/Brimonidine

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Bimatoprost Ophthalmic Solution 0.01% and Vehicle

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Brimonidine Tartrate Ophthalmic Solution 0.2%

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fixed-Combination Bimatoprost/Brimonidine n=38 participants at risk One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.	Bimatoprost Ophthalmic Solution 0.01% and Vehicle n=36 participants at risk One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.	Brimonidine Tartrate Ophthalmic Solution 0.2% n=38 participants at risk One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.00% 0/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	2.8% 1/36 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	0.00% 0/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
Cardiac disorders Acute Myocardial Infarction	0.00% 0/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	0.00% 0/36 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	2.6% 1/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.

Other adverse events

Other adverse events
Measure	Fixed-Combination Bimatoprost/Brimonidine n=38 participants at risk One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.	Bimatoprost Ophthalmic Solution 0.01% and Vehicle n=36 participants at risk One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.	Brimonidine Tartrate Ophthalmic Solution 0.2% n=38 participants at risk One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
Eye disorders Conjunctival Hyperaemia	47.4% 18/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	44.4% 16/36 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	5.3% 2/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
Eye disorders Eye Pruritus	13.2% 5/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	13.9% 5/36 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	7.9% 3/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
Eye disorders Eye Discharge	7.9% 3/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	2.8% 1/36 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	2.6% 1/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
Eye disorders Blepharospasm	7.9% 3/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	0.00% 0/36 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	0.00% 0/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
Eye disorders Punctate Keratitis	5.3% 2/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	11.1% 4/36 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	5.3% 2/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
Eye disorders Eye Pain	5.3% 2/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	2.8% 1/36 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	5.3% 2/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
General disorders Instillation Site Pruritus	5.3% 2/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	2.8% 1/36 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	0.00% 0/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
Eye disorders Foreign Body Sensation in Eyes	5.3% 2/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	0.00% 0/36 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	2.6% 1/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
General disorders Instillation Site Lacrimation	5.3% 2/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	0.00% 0/36 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	0.00% 0/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
Eye disorders Vision Blurred	2.6% 1/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	2.8% 1/36 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	5.3% 2/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
Eye disorders Eye Irritation	0.00% 0/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	8.3% 3/36 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	2.6% 1/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
Infections and infestations Nasopharyngitis	0.00% 0/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	5.6% 2/36 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	0.00% 0/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
Gastrointestinal disorders Dry Mouth	0.00% 0/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	2.8% 1/36 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	10.5% 4/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
Musculoskeletal and connective tissue disorders Spinal Column Stenosis	0.00% 0/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	0.00% 0/36 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.	5.3% 2/38 Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.

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