Trial Outcomes & Findings for A Safety and Efficacy Study of ALPHAGAN® P and LUMIGAN® in Subjects Previously Treated With Latanoprost for Glaucoma and Ocular Hypertension (NCT NCT01525173)

NCT ID: NCT01525173

Last Updated: 2013-12-04

Results Overview

IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the study eye, defined as the worse eye at Baseline. The mean diurnal IOP is the average of all the IOP measurements in the study eye taken at 8 AM, 10 AM and 4 PM at Baseline and at Week 12. A negative change from Baseline indicated improvement.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 137 participants
• Primary outcome timeframe: Baseline, Week 12
• Results posted on: 2013-12-04

Participant Flow

Participant milestones

Measure	ALPHAGAN® P and LUMIGAN® 1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.	LUMIGAN® Alone 1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
Overall Study STARTED	70	67
Overall Study COMPLETED	63	62
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Safety and Efficacy Study of ALPHAGAN® P and LUMIGAN® in Subjects Previously Treated With Latanoprost for Glaucoma and Ocular Hypertension

Baseline characteristics by cohort

Measure	ALPHAGAN® P and LUMIGAN® n=70 Participants 1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.	LUMIGAN® Alone n=67 Participants 1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.	Total n=137 Participants Total of all reporting groups
Age Continuous	65.7 Years STANDARD_DEVIATION 11.87 • n=5 Participants	61.1 Years STANDARD_DEVIATION 13.91 • n=7 Participants	63.4 Years STANDARD_DEVIATION 13.06 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	33 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	34 Participants n=7 Participants	73 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Per protocol population included all qualified participants who completed three months of treatment.

IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the study eye, defined as the worse eye at Baseline. The mean diurnal IOP is the average of all the IOP measurements in the study eye taken at 8 AM, 10 AM and 4 PM at Baseline and at Week 12. A negative change from Baseline indicated improvement.

Outcome measures

Measure	ALPHAGAN® P and LUMIGAN® n=61 Participants 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.	LUMIGAN® Alone n=59 Participants 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) Baseline	22.3 mm Hg Standard Deviation 2.22	22.2 mm Hg Standard Deviation 2.44
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) Change from Baseline at Week 12	-4.7 mm Hg Standard Deviation 2.55	-4.0 mm Hg Standard Deviation 3.23

Adverse Events

ALPHAGAN® P and LUMIGAN®

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

LUMIGAN® Alone

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	ALPHAGAN® P and LUMIGAN® n=70 participants at risk 1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.	LUMIGAN® Alone n=67 participants at risk 1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
Cardiac disorders Prolonged hospitalization cardiac ischemia	0.00% 0/70	1.5% 1/67
Psychiatric disorders Exacerbation of depression disorder	0.00% 0/70	1.5% 1/67
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Esophageal cancer	1.4% 1/70	0.00% 0/67

Other adverse events

Measure	ALPHAGAN® P and LUMIGAN® n=70 participants at risk 1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.	LUMIGAN® Alone n=67 participants at risk 1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
Eye disorders Ocular hyperemia	5.7% 4/70	0.00% 0/67

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