Trial Outcomes & Findings for Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension (NCT NCT01177098)

NCT ID: NCT01177098

Last Updated: 2013-03-29

Results Overview

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 561 participants
• Primary outcome timeframe: Baseline, Week 12
• Results posted on: 2013-03-29

Participant Flow

Participant milestones

Measure	Bimatoprost/Timolol Formulation A One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.	Bimatoprost/Timolol Fixed Combination Ophthalmic Solution One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Overall Study STARTED	278	283
Overall Study COMPLETED	269	271
Overall Study NOT COMPLETED	9	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Baseline characteristics by cohort

Measure	Bimatoprost/Timolol Formulation A n=278 Participants One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.	Bimatoprost/Timolol Fixed Combination Ophthalmic Solution n=283 Participants One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.	Total n=561 Participants Total of all reporting groups
Age, Customized <45 Years	12 Participants 10.61 • n=5 Participants	13 Participants 10.82 • n=7 Participants	25 Participants 10.71 • n=5 Participants
Age, Customized 45 to 65 Years	132 Participants n=5 Participants	135 Participants n=7 Participants	267 Participants n=5 Participants
Age, Customized >65 Years	134 Participants n=5 Participants	135 Participants n=7 Participants	269 Participants n=5 Participants
Sex: Female, Male Female	159 Participants n=5 Participants	162 Participants n=7 Participants	321 Participants n=5 Participants
Sex: Female, Male Male	119 Participants n=5 Participants	121 Participants n=7 Participants	240 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Per-protocol population included randomized participants who did not have a protocol violation that significantly affected the conduct or the results of the trial.

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).

Outcome measures

Measure	Bimatoprost/Timolol Formulation A n=256 Participants One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.	Bimatoprost/Timolol Fixed Combination Ophthalmic Solution n=260 Participants One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 Change from baseline at Week 12_Hour 0 (n=244,237)	-9.06 mm Hg Standard Deviation 3.216	-8.72 mm Hg Standard Deviation 3.088
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 Change from baseline at Week 12_Hour 2 (n=235,235)	-8.53 mm Hg Standard Deviation 3.520	-8.38 mm Hg Standard Deviation 3.297
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 Change from baseline at Week 12_Hour 8 (n=237,234)	-7.98 mm Hg Standard Deviation 3.435	-7.72 mm Hg Standard Deviation 3.172
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 Baseline_Hour 0	25.41 mm Hg Standard Deviation 2.232	25.38 mm Hg Standard Deviation 2.209
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 Baseline_Hour 2 (n=255,260)	24.79 mm Hg Standard Deviation 2.676	24.72 mm Hg Standard Deviation 2.470
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 Baseline_Hour 8 (n=254,259)	23.88 mm Hg Standard Deviation 3.008	23.82 mm Hg Standard Deviation 2.747

PRIMARY outcome

Timeframe: Week 2

Population: Intent-to-treat population included all randomized participants.

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8.

Outcome measures

Measure	Bimatoprost/Timolol Formulation A n=278 Participants One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.	Bimatoprost/Timolol Fixed Combination Ophthalmic Solution n=283 Participants One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2 Week 2_Hour 0	16.23 mm Hg Standard Deviation 2.746	16.49 mm Hg Standard Deviation 2.887
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2 Week 2_Hour 2	16.05 mm Hg Standard Deviation 2.877	16.23 mm Hg Standard Deviation 2.826
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2 Week 2_Hour 8	15.49 mm Hg Standard Deviation 2.596	15.83 mm Hg Standard Deviation 2.987

PRIMARY outcome

Timeframe: Week 6

Population: Intent-to-treat population included all randomized participants.

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8.

Outcome measures

Measure	Bimatoprost/Timolol Formulation A n=278 Participants One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.	Bimatoprost/Timolol Fixed Combination Ophthalmic Solution n=283 Participants One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6 Week 6_Hour 0	16.28 mm Hg Standard Deviation 2.754	16.31 mm Hg Standard Deviation 2.874
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6 Week 6_Hour 2	15.90 mm Hg Standard Deviation 2.910	16.17 mm Hg Standard Deviation 2.894
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6 Week 6_Hour 8	15.71 mm Hg Standard Deviation 2.755	15.82 mm Hg Standard Deviation 2.926

PRIMARY outcome

Timeframe: Week 12

Population: Intent-to-treat population included all randomized participants.

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8.

Outcome measures

Measure	Bimatoprost/Timolol Formulation A n=278 Participants One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.	Bimatoprost/Timolol Fixed Combination Ophthalmic Solution n=283 Participants One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 Week 12_Hour 0	16.29 mm Hg Standard Deviation 2.783	16.56 mm Hg Standard Deviation 2.643
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 Week 12_Hour 2	16.18 mm Hg Standard Deviation 2.845	16.37 mm Hg Standard Deviation 2.699
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12 Week 12_Hour 8	15.85 mm Hg Standard Deviation 2.786	16.09 mm Hg Standard Deviation 2.714

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Intent-to-treat population included all randomized participants.

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).

Outcome measures

Measure	Bimatoprost/Timolol Formulation A n=278 Participants One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.	Bimatoprost/Timolol Fixed Combination Ophthalmic Solution n=283 Participants One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 Baseline_Hour 0	25.34 mm Hg Standard Deviation 2.233	25.30 mm Hg Standard Deviation 2.244
Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 Baseline_Hour 2	24.71 mm Hg Standard Deviation 2.700	24.61 mm Hg Standard Deviation 2.536
Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 Baseline_Hour 8	23.81 mm Hg Standard Deviation 2.989	23.80 mm Hg Standard Deviation 2.795
Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 Change from baseline at Week 12_Hour 0	-8.94 mm Hg Standard Deviation 3.290	-8.51 mm Hg Standard Deviation 3.253
Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 Change from baseline at Week 12_Hour 2	-8.44 mm Hg Standard Deviation 3.646	-8.08 mm Hg Standard Deviation 3.504
Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12 Change from baseline at Week 12_Hour 8	-7.87 mm Hg Standard Deviation 3.496	-7.52 mm Hg Standard Deviation 3.362

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Intent-to-treat population included all randomized participants.

Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8. Average eye IOP is defined as the average of the IOP in both eyes. A negative number change from baseline indicates a reduction in IOP (improvement).

Outcome measures

Measure	Bimatoprost/Timolol Formulation A n=278 Participants One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.	Bimatoprost/Timolol Fixed Combination Ophthalmic Solution n=283 Participants One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 Baseline_Hour 0	24.94 mm Hg Standard Deviation 2.116	24.86 mm Hg Standard Deviation 2.131
Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 Baseline_Hour 2	24.29 mm Hg Standard Deviation 2.515	24.23 mm Hg Standard Deviation 2.426
Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 Baseline_Hour 8	23.42 mm Hg Standard Deviation 2.904	23.36 mm Hg Standard Deviation 2.703
Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 Change from baseline at Week 12_Hour 0	-8.65 mm Hg Standard Deviation 3.109	-8.30 mm Hg Standard Deviation 3.009
Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 Change from baseline at Week 12_Hour 2	-8.11 mm Hg Standard Deviation 3.392	-7.86 mm Hg Standard Deviation 3.413
Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12 Change from baseline at Week 12_Hour 8	-7.57 mm Hg Standard Deviation 3.395	-7.27 mm Hg Standard Deviation 3.226

Adverse Events

Bimatoprost/Timolol Formulation A

Serious events: 4 serious events

Other events: 59 other events

Deaths: 0 deaths

Bimatoprost/Timolol Fixed Combination Ophthalmic Solution

Serious events: 4 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bimatoprost/Timolol Formulation A n=278 participants at risk One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.	Bimatoprost/Timolol Fixed Combination Ophthalmic Solution n=282 participants at risk One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Vascular disorders Intermittent claudication	0.36% 1/278 The safety population (all treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/282 The safety population (all treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.36% 1/278 The safety population (all treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/282 The safety population (all treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.36% 1/278 The safety population (all treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/282 The safety population (all treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.36% 1/278 The safety population (all treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.	0.00% 0/282 The safety population (all treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
Nervous system disorders Cerebellar infarction	0.00% 0/278 The safety population (all treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.	0.35% 1/282 The safety population (all treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/278 The safety population (all treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.	0.35% 1/282 The safety population (all treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/278 The safety population (all treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.	0.35% 1/282 The safety population (all treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
General disorders Non-cardiac chest pain	0.00% 0/278 The safety population (all treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.	0.35% 1/282 The safety population (all treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.

Other adverse events

Measure	Bimatoprost/Timolol Formulation A n=278 participants at risk One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.	Bimatoprost/Timolol Fixed Combination Ophthalmic Solution n=282 participants at risk One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Eye disorders Conjunctival hyperaemia	21.2% 59/278 The safety population (all treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.	19.5% 55/282 The safety population (all treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.

Additional Information

Therapeutic Area Head,

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