Safety and Efficacy of AGN-199201 and AGN-190584 in Patients With Presbyopia

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02197806
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Arms: 4
• Duration (Months): 4
• Patients Per Site Per Month: 16.1

Study Details

Study Description

Brief Summary

A study to evaluate the safety and efficacy of AGN-199201 alone, AGN-190584 alone and concurrent use of AGN-199201 and AGN-190584 in patients with presbyopia (inability to focus for near vision).

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Drug: AGN-199201; Drug: AGN-190584; Drug: AGN-199201 Vehicle	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AGN-199201 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.	Drug: AGN-199201; 1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.; Drug: AGN-199201 Vehicle; 1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.
Experimental: AGN-190584 1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.	Drug: AGN-190584; 1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.; Drug: AGN-199201 Vehicle; 1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.
Experimental: AGN-199201 + AGN-190584 in One Eye 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.	Drug: AGN-199201; 1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.; Drug: AGN-190584; 1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.; Drug: AGN-199201 Vehicle; 1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.
Experimental: AGN-199201 + AGN-190584 in Both Eyes 1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.	Drug: AGN-199201; 1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.; Drug: AGN-190584; 1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye [Baseline, Day 3]

   UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved. The percentages of patients with at least a 2 or more line improvement in UNVA in the non-dominant eye are presented.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

-Presbyopia in each eye that impacts daily activities.

Exclusion Criteria:

• Use of any topical ophthalmic medications, including artificial tears

• Contact lens use in either eye within 14 days or planned use during the study

• History of eye surgery

• Diagnosis of any type of glaucoma or ocular hypertension

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Newport Beach	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: NCT02197806
• Other Study ID Numbers: 199201-007
• First Posted: Jul 23, 2014
• Last Update Posted: Dec 3, 2015
• Last Verified: Oct 1, 2015

• Additional relevant MeSH terms: Presbyopia

Study Results

Participant Flow

Arm/Group Title	AGN-199201	AGN-190584	AGN-199201 + AGN-190584 in One Eye	AGN-199201 + AGN-190584 in Both Eyes
Arm/Group Description	1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.	1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.	1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.	1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
Period Title: Overall Study
STARTED	15	17	16	17
COMPLETED	15	16	16	16
NOT COMPLETED	0	1	0	1

Baseline Characteristics

Arm/Group Title	AGN-199201	AGN-190584	AGN-199201 + AGN-190584 in One Eye	AGN-199201 + AGN-190584 in Both Eyes	Total
Arm/Group Description	1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.	1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.	1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.	1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.	Total of all reporting groups
Overall Participants	15	17	16	17	65
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	49.9 (3.88)	49.1 (3.47)	48.7 (4.16)	49.1 (3.97)	49.2 (3.81)
Sex: Female, Male (Count of Participants)
Female	13 86.7%	13 76.5%	7 43.8%	10 58.8%	43 66.2%
Male	2 13.3%	4 23.5%	9 56.3%	7 41.2%	22 33.8%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye
Description	UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved. The percentages of patients with at least a 2 or more line improvement in UNVA in the non-dominant eye are presented.
Time Frame	Baseline, Day 3

Outcome Measure Data

Analysis Population Description

Modified Intent to Treat: all randomized patients with a baseline assessment and at least 1 postbaseline assessment of UNVA

Arm/Group Title	AGN-199201	AGN-190584	AGN-199201 + AGN-190584 in One Eye	AGN-199201 + AGN-190584 in Both Eyes
Arm/Group Description	1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.	1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.	1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.	1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
Measure Participants	15	17	16	16
Number [Percentage of Patients]	46.7	70.6	56.3	68.8

Adverse Events

Adverse Event Reporting Description	The Safety Population included all patients who received at least 1 dose of study treatment and was used to assess adverse events (AEs) and serious adverse events (SAEs).
Arm/Group Title	AGN-199201		AGN-190584		AGN-199201 + AGN-190584 in One Eye		AGN-199201 + AGN-190584 in Both Eyes
Arm/Group Description	1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.		1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.		1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.		1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
All Cause Mortality
	AGN-199201		AGN-190584		AGN-199201 + AGN-190584 in One Eye		AGN-199201 + AGN-190584 in Both Eyes
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	AGN-199201		AGN-190584		AGN-199201 + AGN-190584 in One Eye		AGN-199201 + AGN-190584 in Both Eyes
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/17 (0%)		0/16 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	AGN-199201		AGN-190584		AGN-199201 + AGN-190584 in One Eye		AGN-199201 + AGN-190584 in Both Eyes
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/15 (33.3%)		4/17 (23.5%)		8/16 (50%)		5/17 (29.4%)
Eye disorders
Vision Blurred	0/15 (0%)		1/17 (5.9%)		2/16 (12.5%)		1/17 (5.9%)
Conjunctival Hyperaemia	0/15 (0%)		1/17 (5.9%)		1/16 (6.3%)		1/17 (5.9%)
Lacrimation Increased	0/15 (0%)		1/17 (5.9%)		1/16 (6.3%)		1/17 (5.9%)
Metamorphopsia	0/15 (0%)		0/17 (0%)		0/16 (0%)		1/17 (5.9%)
Ocular Discomfort	0/15 (0%)		0/17 (0%)		2/16 (12.5%)		0/17 (0%)
Eyelid Retraction	4/15 (26.7%)		0/17 (0%)		1/16 (6.3%)		0/17 (0%)
Photophobia	0/15 (0%)		0/17 (0%)		1/16 (6.3%)		0/17 (0%)
Eye Irritation	0/15 (0%)		1/17 (5.9%)		0/16 (0%)		0/17 (0%)
Punctate Keratitis	1/15 (6.7%)		0/17 (0%)		0/16 (0%)		0/17 (0%)
Gastrointestinal disorders
Nausea	0/15 (0%)		0/17 (0%)		0/16 (0%)		1/17 (5.9%)
General disorders
Product Taste Abnormal	0/15 (0%)		0/17 (0%)		0/16 (0%)		1/17 (5.9%)
Discomfort	0/15 (0%)		0/17 (0%)		1/16 (6.3%)		0/17 (0%)
Infections and infestations
Upper Respiratory Tract Infection	1/15 (6.7%)		0/17 (0%)		0/16 (0%)		0/17 (0%)
Investigations
Blood Pressure Increased	0/15 (0%)		1/17 (5.9%)		0/16 (0%)		0/17 (0%)
Nervous system disorders
Headache	0/15 (0%)		0/17 (0%)		2/16 (12.5%)		3/17 (17.6%)

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.