Trial Outcomes & Findings for Safety and Efficacy of Three Formulations of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution (NCT NCT01001195)

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

PHASE2

Target enrollment

165 participants

Primary outcome timeframe

Baseline, Day 29 Hour 0

Results posted on

2013-10-18

Participant Flow

Participant milestones

Participant milestones
Measure	AGN-210669 Ophthalmic Solution, 0.1% One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.	AGN-210669 Ophthalmic Solution, 0.075% One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.	AGN-210669 Ophthalmic Solution, 0.05% One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.	Bimatoprost Ophthalmic Solution 0.03% One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
Overall Study STARTED	39	41	44	41
Overall Study COMPLETED	37	39	44	41
Overall Study NOT COMPLETED	2	2	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Three Formulations of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AGN-210669 Ophthalmic Solution, 0.1% n=39 Participants One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.	AGN-210669 Ophthalmic Solution, 0.075% n=41 Participants One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.	AGN-210669 Ophthalmic Solution, 0.05% n=44 Participants One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.	Bimatoprost Ophthalmic Solution 0.03% n=41 Participants One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.	Total n=165 Participants Total of all reporting groups
Age, Customized <45 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Age, Customized 45 to 65 years	22 Participants n=5 Participants	24 Participants n=7 Participants	21 Participants n=5 Participants	21 Participants n=4 Participants	88 Participants n=21 Participants
Age, Customized >65 years	16 Participants n=5 Participants	16 Participants n=7 Participants	21 Participants n=5 Participants	20 Participants n=4 Participants	73 Participants n=21 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	22 Participants n=7 Participants	23 Participants n=5 Participants	18 Participants n=4 Participants	87 Participants n=21 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	19 Participants n=7 Participants	21 Participants n=5 Participants	23 Participants n=4 Participants	78 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Day 29 Hour 0

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

Outcome measures

Outcome measures
Measure	AGN-210669 Ophthalmic Solution, 0.1% n=39 Participants One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.	AGN-210669 Ophthalmic Solution, 0.075% n=41 Participants One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.	AGN-210669 Ophthalmic Solution, 0.05% n=44 Participants One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.	Bimatoprost Ophthalmic Solution 0.03% n=41 Participants One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
Change From Baseline in Average Eye Intraocular Pressure (IOP) Baseline - Hour 0	25.88 Millimeters of Mercury (mmHg) Standard Deviation 3.696	25.18 Millimeters of Mercury (mmHg) Standard Deviation 2.382	25.39 Millimeters of Mercury (mmHg) Standard Deviation 2.770	25.73 Millimeters of Mercury (mmHg) Standard Deviation 3.490
Change From Baseline in Average Eye Intraocular Pressure (IOP) Change from Baseline at Day 29 - Hour 0	-7.50 Millimeters of Mercury (mmHg) Standard Deviation 4.219	-7.65 Millimeters of Mercury (mmHg) Standard Deviation 3.171	-5.66 Millimeters of Mercury (mmHg) Standard Deviation 3.082	-8.57 Millimeters of Mercury (mmHg) Standard Deviation 3.854

Adverse Events

AGN-210669 Ophthalmic Solution, 0.1%

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

AGN-210669 Ophthalmic Solution, 0.075%

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

AGN-210669 Ophthalmic Solution, 0.05%

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Bimatoprost Ophthalmic Solution 0.03%

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AGN-210669 Ophthalmic Solution, 0.1% n=39 participants at risk One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.	AGN-210669 Ophthalmic Solution, 0.075% n=41 participants at risk One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.	AGN-210669 Ophthalmic Solution, 0.05% n=44 participants at risk One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.	Bimatoprost Ophthalmic Solution 0.03% n=41 participants at risk One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
Hepatobiliary disorders Cholecystitis	2.6% 1/39 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	0.00% 0/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	0.00% 0/44 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	0.00% 0/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).

Other adverse events

Other adverse events
Measure	AGN-210669 Ophthalmic Solution, 0.1% n=39 participants at risk One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.	AGN-210669 Ophthalmic Solution, 0.075% n=41 participants at risk One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.	AGN-210669 Ophthalmic Solution, 0.05% n=44 participants at risk One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.	Bimatoprost Ophthalmic Solution 0.03% n=41 participants at risk One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
Eye disorders Conjunctival Hyperaemia	53.8% 21/39 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	56.1% 23/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	29.5% 13/44 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	61.0% 25/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).
Eye disorders Punctate Keratitis	12.8% 5/39 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	7.3% 3/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	9.1% 4/44 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	7.3% 3/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).
Eye disorders Photophobia	10.3% 4/39 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	12.2% 5/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	4.5% 2/44 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	2.4% 1/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).
Eye disorders Eye Pain	7.7% 3/39 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	9.8% 4/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	0.00% 0/44 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	2.4% 1/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).
Eye disorders Vision Blurred	5.1% 2/39 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	12.2% 5/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	4.5% 2/44 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	2.4% 1/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).
Eye disorders Foreign Body Sensation in Eyes	5.1% 2/39 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	9.8% 4/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	0.00% 0/44 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	2.4% 1/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).
Eye disorders Anterior Chamber Cell	5.1% 2/39 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	2.4% 1/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	2.3% 1/44 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	0.00% 0/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).
Eye disorders Eye Irritation	5.1% 2/39 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	2.4% 1/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	0.00% 0/44 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	4.9% 2/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).
General disorders Instillation Site Pain	5.1% 2/39 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	2.4% 1/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	0.00% 0/44 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	2.4% 1/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).
Eye disorders Eye Pruritus	0.00% 0/39 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	2.4% 1/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	2.3% 1/44 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).	7.3% 3/41 The Safety Population consisted of all randomized and treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs).

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