Trial Outcomes & Findings for Safety and Efficacy of AGN 210669 Ophthalmic Solution in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma (NCT NCT00809848)

NCT ID: NCT00809848

Last Updated: 2013-10-18

Results Overview

IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. 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: PHASE1/PHASE2
• Target enrollment: 172 participants
• Primary outcome timeframe: Baseline, Day 14 Hour 0
• Results posted on: 2013-10-18

Participant Flow

Participant milestones

Measure	AGN-210669 Ophthalmic Solution, 0.075% AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.	AGN-210669 Ophthalmic Solution, 0.05% AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.	AGN-210669 Ophthalmic Solution, 0.025% AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.	Bimatoprost Ophthalmic Solution 0.03% Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.	AGN-210669 Vehicle Ophthalmic Solution AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
Overall Study STARTED	36	34	34	31	37
Overall Study COMPLETED	36	34	34	30	34
Overall Study NOT COMPLETED	0	0	0	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of AGN 210669 Ophthalmic Solution in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma

Baseline characteristics by cohort

Measure	AGN-210669 Ophthalmic Solution, 0.075% n=36 Participants AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.	AGN-210669 Ophthalmic Solution, 0.05% n=34 Participants AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.	AGN-210669 Ophthalmic Solution, 0.025% n=34 Participants AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.	Bimatoprost Ophthalmic Solution 0.03% n=31 Participants Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.	AGN-210669 Vehicle Ophthalmic Solution n=37 Participants AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.	Total n=172 Participants Total of all reporting groups
Age, Customized <45 years	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	7 Participants n=8 Participants
Age, Customized Between 45 and 65 years	23 Participants n=5 Participants	20 Participants n=7 Participants	18 Participants n=5 Participants	18 Participants n=4 Participants	18 Participants n=21 Participants	97 Participants n=8 Participants
Age, Customized >65 years	12 Participants n=5 Participants	14 Participants n=7 Participants	14 Participants n=5 Participants	12 Participants n=4 Participants	16 Participants n=21 Participants	68 Participants n=8 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	18 Participants n=7 Participants	21 Participants n=5 Participants	20 Participants n=4 Participants	20 Participants n=21 Participants	101 Participants n=8 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	16 Participants n=7 Participants	13 Participants n=5 Participants	11 Participants n=4 Participants	17 Participants n=21 Participants	71 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline, Day 14 Hour 0

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

IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. 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).

Outcome measures

Measure	AGN-210669 Ophthalmic Solution, 0.075% n=35 Participants AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.	AGN-210669 Ophthalmic Solution, 0.05% n=33 Participants AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.	AGN-210669 Ophthalmic Solution, 0.025% n=33 Participants AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.	Bimatoprost Ophthalmic Solution 0.03% n=30 Participants Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.	AGN-210669 Vehicle Ophthalmic Solution n=36 Participants AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
Change From Baseline in Average Eye Intraocular Pressure (IOP) Baseline - Hour 0	25.350 Millimeters of Mercury (mmHg) Standard Deviation 2.8018	25.318 Millimeters of Mercury (mmHg) Standard Deviation 2.9377	25.341 Millimeters of Mercury (mmHg) Standard Deviation 2.6375	24.650 Millimeters of Mercury (mmHg) Standard Deviation 2.0622	25.507 Millimeters of Mercury (mmHg) Standard Deviation 2.9004
Change From Baseline in Average Eye Intraocular Pressure (IOP) Change from Baseline at Day 14 - Hour 0	-5.807 Millimeters of Mercury (mmHg) Standard Deviation 3.7007	-5.197 Millimeters of Mercury (mmHg) Standard Deviation 3.1947	-4.068 Millimeters of Mercury (mmHg) Standard Deviation 2.8520	-6.575 Millimeters of Mercury (mmHg) Standard Deviation 3.2184	-2.382 Millimeters of Mercury (mmHg) Standard Deviation 2.9396

SECONDARY outcome

Timeframe: Baseline, Day 14

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

IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP is the average of the IOP values of both eyes at each time point measured at protocol-specified times throughout the day.

Outcome measures

Measure	AGN-210669 Ophthalmic Solution, 0.075% n=35 Participants AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.	AGN-210669 Ophthalmic Solution, 0.05% n=33 Participants AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.	AGN-210669 Ophthalmic Solution, 0.025% n=33 Participants AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.	Bimatoprost Ophthalmic Solution 0.03% n=30 Participants Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.	AGN-210669 Vehicle Ophthalmic Solution n=36 Participants AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP	62.9 Percentage of Patients	57.6 Percentage of Patients	30.3 Percentage of Patients	63.3 Percentage of Patients	2.8 Percentage of Patients

Adverse Events

AGN-210669 Ophthalmic Solution, 0.075%

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

AGN-210669 Ophthalmic Solution, 0.05%

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

AGN-210669 Ophthalmic Solution, 0.025%

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Bimatoprost Ophthalmic Solution 0.03%

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

AGN-210669 Vehicle Ophthalmic Solution

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	AGN-210669 Ophthalmic Solution, 0.075% n=36 participants at risk AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.	AGN-210669 Ophthalmic Solution, 0.05% n=34 participants at risk AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.	AGN-210669 Ophthalmic Solution, 0.025% n=34 participants at risk AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.	Bimatoprost Ophthalmic Solution 0.03% n=31 participants at risk Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.	AGN-210669 Vehicle Ophthalmic Solution n=37 participants at risk AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
Eye disorders Conjunctival Hyperaemia	27.8% 10/36 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	32.4% 11/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	14.7% 5/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	38.7% 12/31 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	8.1% 3/37 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.
Eye disorders Photophobia	8.3% 3/36 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	0.00% 0/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	0.00% 0/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	0.00% 0/31 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	0.00% 0/37 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.
Eye disorders Eye Pain	5.6% 2/36 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	2.9% 1/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	0.00% 0/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	0.00% 0/31 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	0.00% 0/37 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.
Eye disorders Vision Blurred	0.00% 0/36 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	8.8% 3/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	2.9% 1/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	0.00% 0/31 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	0.00% 0/37 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.
Eye disorders Punctate Keratitis	0.00% 0/36 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	5.9% 2/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	5.9% 2/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	3.2% 1/31 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	2.7% 1/37 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.
Eye disorders Lacrimation Increased	2.8% 1/36 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	0.00% 0/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	2.9% 1/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	6.5% 2/31 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	2.7% 1/37 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.
Eye disorders Eye Irritation	2.8% 1/36 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	0.00% 0/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	0.00% 0/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	9.7% 3/31 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	0.00% 0/37 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.
Eye disorders Dry Eye	0.00% 0/36 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	2.9% 1/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	0.00% 0/34 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	6.5% 2/31 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.	0.00% 0/37 The Safety Population was used to assess adverse events (AEs) and serious adverse events (SAEs), and included all patients who were randomized and received at least 1 dose of study drug.

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