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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00809848
• Collaborator: (none)
• Enrollment: 172
• Location: 1
• Arms: 5
• Duration (Months): 2.9
• Patients Per Site Per Month: 58.8

Study Details

Study Description

Brief Summary

The study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will be followed for 2 weeks.

Condition or Disease	Intervention/Treatment	Phase
Ocular Hypertension; Glaucoma	Drug: AGN-210669 ophthalmic solution, 0.075%; Drug: AGN-210669 ophthalmic solution, 0.05%; Drug: AGN-210669 ophthalmic solution, 0.025%; Drug: bimatoprost ophthalmic solution 0.03%; Drug: AGN-210669 vehicle ophthalmic solution	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 172 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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.
Experimental: 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.	Drug: 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.
Experimental: 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.	Drug: 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.
Active Comparator: bimatoprost ophthalmic solution 0.03% Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.	Drug: bimatoprost ophthalmic solution 0.03%; Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.; Other Names: Lumigan®
Placebo Comparator: AGN-210669 vehicle ophthalmic solution AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.	Drug: AGN-210669 vehicle ophthalmic solution; AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Average Eye Intraocular Pressure (IOP) [Baseline, Day 14 Hour 0]

   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).

Secondary Outcome Measures

1. Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP [Baseline, Day 14]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ocular hypertension or primary open-angle glaucoma

• Females of non-childbearing potential

• Subject requires IOP-lowering therapy in both eyes

• IOP ≥ 22 mm Hg and ≤ 34 mm Hg

• Has a visual acuity score of 20/100 or better in each eye

Exclusion Criteria:

• Uncontrolled systemic disease

• Active ocular disease

• Alteration of existing chronic systemic medications

• Known allergy or sensitivity to the study medications

• Ophthalmic corticosteroids

• Visual field loss which in the opinion of the investigator is functionally significant

• History of ocular laser, intraocular surgery, or refractive surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Artesia	California	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT00809848
• Other Study ID Numbers: 210669-003
• First Posted: Dec 17, 2008
• Last Update Posted: Oct 18, 2013
• Last Verified: Aug 1, 2013

• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Hypertension; Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	AGN-210669 Ophthalmic Solution, 0.075%	AGN-210669 Ophthalmic Solution, 0.05%	AGN-210669 Ophthalmic Solution, 0.025%	Bimatoprost Ophthalmic Solution 0.03%	AGN-210669 Vehicle Ophthalmic Solution	Total
Arm/Group Description	AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.	AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.	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%. One drop in both eyes each morning once-daily for 2 weeks.	AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.	Total of all reporting groups
Overall Participants	36	34	34	31	37	172
Age, Customized (Number) [Number]
<45 years	1 2.8%	0 0%	2 5.9%	1 3.2%	3 8.1%	7 4.1%
Between 45 and 65 years	23 63.9%	20 58.8%	18 52.9%	18 58.1%	18 48.6%	97 56.4%
>65 years	12 33.3%	14 41.2%	14 41.2%	12 38.7%	16 43.2%	68 39.5%
Sex: Female, Male (Count of Participants)
Female	22 61.1%	18 52.9%	21 61.8%	20 64.5%	20 54.1%	101 58.7%
Male	14 38.9%	16 47.1%	13 38.2%	11 35.5%	17 45.9%	71 41.3%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Average Eye Intraocular Pressure (IOP)
Description	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).
Time Frame	Baseline, Day 14 Hour 0

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AGN-210669 Ophthalmic Solution, 0.075%	AGN-210669 Ophthalmic Solution, 0.05%	AGN-210669 Ophthalmic Solution, 0.025%	Bimatoprost Ophthalmic Solution 0.03%	AGN-210669 Vehicle Ophthalmic Solution
Arm/Group Description	AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.	AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.	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%. One drop in both eyes each morning once-daily for 2 weeks.	AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
Measure Participants	35	33	33	30	36
Baseline - Hour 0	25.350 (2.8018)	25.318 (2.9377)	25.341 (2.6375)	24.650 (2.0622)	25.507 (2.9004)
Change from Baseline at Day 14 - Hour 0	-5.807 (3.7007)	-5.197 (3.1947)	-4.068 (2.8520)	-6.575 (3.2184)	-2.382 (2.9396)

2. Secondary Outcome

Title	Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP
Description	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.
Time Frame	Baseline, Day 14

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	AGN 210669 Non-preserved Ophthalmic Solution, 0.075%	AGN-210669 Ophthalmic Solution, 0.05%	AGN-210669 Ophthalmic Solution, 0.025%	Bimatoprost Ophthalmic Solution 0.03%	AGN-210669 Vehicle Ophthalmic Solution
Arm/Group Description	AGN 210669 non-preserved ophthalmic solution, 0.075%. One drop in each eye each morning once-daily for 2 weeks.	AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.	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%. One drop in both eyes each morning once-daily for 2 weeks.	AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
Measure Participants	35	33	33	30	36
Number [Percentage of Patients]	62.9	57.6	30.3	63.3	2.8

Adverse Events

Adverse Event Reporting Description	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.
Arm/Group Title	AGN-210669 Ophthalmic Solution, 0.075%		AGN-210669 Ophthalmic Solution, 0.05%		AGN-210669 Ophthalmic Solution, 0.025%		Bimatoprost Ophthalmic Solution 0.03%		AGN-210669 Vehicle Ophthalmic Solution
Arm/Group Description	AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.		AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.		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%. One drop in both eyes each morning once-daily for 2 weeks.		AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
All Cause Mortality
	AGN-210669 Ophthalmic Solution, 0.075%		AGN-210669 Ophthalmic Solution, 0.05%		AGN-210669 Ophthalmic Solution, 0.025%		Bimatoprost Ophthalmic Solution 0.03%		AGN-210669 Vehicle Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	AGN-210669 Ophthalmic Solution, 0.075%		AGN-210669 Ophthalmic Solution, 0.05%		AGN-210669 Ophthalmic Solution, 0.025%		Bimatoprost Ophthalmic Solution 0.03%		AGN-210669 Vehicle Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/34 (0%)		0/34 (0%)		0/31 (0%)		0/37 (0%)
Other (Not Including Serious) Adverse Events
	AGN-210669 Ophthalmic Solution, 0.075%		AGN-210669 Ophthalmic Solution, 0.05%		AGN-210669 Ophthalmic Solution, 0.025%		Bimatoprost Ophthalmic Solution 0.03%		AGN-210669 Vehicle Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/36 (47.2%)		18/34 (52.9%)		9/34 (26.5%)		20/31 (64.5%)		5/37 (13.5%)
Eye disorders
Conjunctival Hyperaemia	10/36 (27.8%)		11/34 (32.4%)		5/34 (14.7%)		12/31 (38.7%)		3/37 (8.1%)
Photophobia	3/36 (8.3%)		0/34 (0%)		0/34 (0%)		0/31 (0%)		0/37 (0%)
Eye Pain	2/36 (5.6%)		1/34 (2.9%)		0/34 (0%)		0/31 (0%)		0/37 (0%)
Vision Blurred	0/36 (0%)		3/34 (8.8%)		1/34 (2.9%)		0/31 (0%)		0/37 (0%)
Punctate Keratitis	0/36 (0%)		2/34 (5.9%)		2/34 (5.9%)		1/31 (3.2%)		1/37 (2.7%)
Lacrimation Increased	1/36 (2.8%)		0/34 (0%)		1/34 (2.9%)		2/31 (6.5%)		1/37 (2.7%)
Eye Irritation	1/36 (2.8%)		0/34 (0%)		0/34 (0%)		3/31 (9.7%)		0/37 (0%)
Dry Eye	0/36 (0%)		1/34 (2.9%)		0/34 (0%)		2/31 (6.5%)		0/37 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.