Trial Outcomes & Findings for Safety and Pharmacodynamics Study of AGN-207281 Ophthalmic Solutions Compared With Timolol Ophthalmic Solution or Placebo in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma (NCT NCT01215786)

Last Updated: 2015-08-17

Results Overview

Change from baseline in worse eye IOP at day 14. Worse eye IOP refers to the eye with the worse (highest) baseline IOP (a measurement of the fluid pressure inside the eye). A negative number change from baseline indicates a reduction in IOP (improvement).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

50 participants

Primary outcome timeframe

Baseline, Day 14

Results posted on

2015-08-17

Participant Flow

Patients in the AGN-207281 ophthalmic solution arm received AGN-207281 ophthalmic solution 0.1% on Days 1 to 7 and AGN-207281 ophthalmic solution 0.3% on Days 8 to 14.

Participant milestones

Participant milestones
Measure	AGN-207281 Ophthalmic Solution AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14	Timolol Ophthalmic Solution 0.5% timolol ophthalmic solution 0.5%	Placebo AGN-207281 vehicle ophthalmic solution (Placebo)
Overall Study STARTED	21	19	10
Overall Study COMPLETED	21	19	10
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Pharmacodynamics Study of AGN-207281 Ophthalmic Solutions Compared With Timolol Ophthalmic Solution or Placebo in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AGN-207281 Ophthalmic Solution n=21 Participants AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14	Timolol Ophthalmic Solution 0.5% n=19 Participants timolol ophthalmic solution 0.5%	Placebo n=10 Participants AGN-207281 vehicle ophthalmic solution (Placebo)	Total n=50 Participants Total of all reporting groups
Age, Customized <45 years	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Age, Customized Between 45 and 65 years	7 participants n=5 Participants	7 participants n=7 Participants	2 participants n=5 Participants	16 participants n=4 Participants
Age, Customized >65 years	14 participants n=5 Participants	12 participants n=7 Participants	7 participants n=5 Participants	33 participants n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	28 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	11 Participants n=7 Participants	3 Participants n=5 Participants	22 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Day 14

Population: Safety population, which consisted of all patients who started the study and received treatment.

Outcome measures

Outcome measures
Measure	AGN-207281 Ophthalmic Solution n=21 Participants AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14	Timolol Ophthalmic Solution 0.5% n=19 Participants timolol ophthalmic solution 0.5%	Placebo n=10 Participants AGN-207281 vehicle ophthalmic solution (Placebo)
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 Baseline, Hour 0	25.98 Millimeters of mercury (mm Hg) Standard Deviation 2.581	26.58 Millimeters of mercury (mm Hg) Standard Deviation 2.673	26.45 Millimeters of mercury (mm Hg) Standard Deviation 2.661
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 Baseline, Hour 2	25.93 Millimeters of mercury (mm Hg) Standard Deviation 3.207	26.61 Millimeters of mercury (mm Hg) Standard Deviation 3.125	26.30 Millimeters of mercury (mm Hg) Standard Deviation 2.781
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 Baseline, Hour 8	24.69 Millimeters of mercury (mm Hg) Standard Deviation 2.610	24.82 Millimeters of mercury (mm Hg) Standard Deviation 2.578	25.25 Millimeters of mercury (mm Hg) Standard Deviation 2.889
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 Change from Baseline at Day 14, Hour 0	-4.17 Millimeters of mercury (mm Hg) Standard Deviation 2.825	-6.16 Millimeters of mercury (mm Hg) Standard Deviation 3.189	-1.10 Millimeters of mercury (mm Hg) Standard Deviation 2.039
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 Change from Baseline at Day 14, Hour 2	-4.38 Millimeters of mercury (mm Hg) Standard Deviation 3.244	-6.08 Millimeters of mercury (mm Hg) Standard Deviation 2.955	-1.75 Millimeters of mercury (mm Hg) Standard Deviation 2.690
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 Change from Baseline at Day 14, Hour 8	-4.02 Millimeters of mercury (mm Hg) Standard Deviation 2.826	-4.00 Millimeters of mercury (mm Hg) Standard Deviation 3.000	-1.70 Millimeters of mercury (mm Hg) Standard Deviation 1.814

SECONDARY outcome

Timeframe: Day 7

Population: The analysis population included all patients that started the study and were treated with AGN-207281.

Mean concentration of AGN-207281 in plasma at day 7. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 7, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.

Outcome measures

Outcome measures
Measure	AGN-207281 Ophthalmic Solution n=21 Participants AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14	Timolol Ophthalmic Solution 0.5% timolol ophthalmic solution 0.5%	Placebo AGN-207281 vehicle ophthalmic solution (Placebo)
Mean Concentration of AGN-207281 in Plasma at Day 7	177 Picograms per milliliter (pg/mL) Standard Deviation 113	—	—

SECONDARY outcome

Timeframe: Day 14

Population: The analysis population included all patients that started the study and were treated with AGN-207281.

Mean concentration of AGN-207281 in plasma at day 14. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 14, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.

Outcome measures

Outcome measures
Measure	AGN-207281 Ophthalmic Solution n=21 Participants AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14	Timolol Ophthalmic Solution 0.5% timolol ophthalmic solution 0.5%	Placebo AGN-207281 vehicle ophthalmic solution (Placebo)
Mean Concentration of AGN-207281 in Plasma at Day 14	540 Picograms per milliliter (pg/mL) Standard Deviation 263	—	—

Adverse Events

AGN-207281 Ophthalmic Solution

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Timolol Ophthalmic Solution 0.5%

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	AGN-207281 Ophthalmic Solution n=21 participants at risk AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14	Timolol Ophthalmic Solution 0.5% n=19 participants at risk timolol ophthalmic solution 0.5%	Placebo n=10 participants at risk AGN-207281 vehicle ophthalmic solution (Placebo)
Eye disorders Eye irritation	33.3% 7/21	42.1% 8/19	0.00% 0/10
Eye disorders Eye pain	4.8% 1/21	5.3% 1/19	0.00% 0/10
Eye disorders Lacrimation increased	4.8% 1/21	10.5% 2/19	0.00% 0/10
Eye disorders Punctate keratitis	0.00% 0/21	21.1% 4/19	0.00% 0/10
Eye disorders Eye discharge	0.00% 0/21	5.3% 1/19	0.00% 0/10
Eye disorders Vision blurred	0.00% 0/21	5.3% 1/19	0.00% 0/10
Injury, poisoning and procedural complications Joint sprain	0.00% 0/21	5.3% 1/19	0.00% 0/10
Nervous system disorders Headache	0.00% 0/21	5.3% 1/19	0.00% 0/10
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/21	0.00% 0/19	10.0% 1/10
Eye disorders Foreign body sensation in eyes	0.00% 0/21	0.00% 0/19	10.0% 1/10

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