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

NCT ID: NCT02197806

Last Updated: 2015-12-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-11-30

Brief Summary

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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).

Detailed Description

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Conditions

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Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

AGN-199201

Intervention Type DRUG

1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.

AGN-199201 Vehicle

Intervention Type DRUG

1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.

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.

Group Type EXPERIMENTAL

AGN-190584

Intervention Type DRUG

1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.

AGN-199201 Vehicle

Intervention Type DRUG

1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.

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.

Group Type EXPERIMENTAL

AGN-199201

Intervention Type DRUG

1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.

AGN-190584

Intervention Type DRUG

1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.

AGN-199201 Vehicle

Intervention Type DRUG

1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.

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.

Group Type EXPERIMENTAL

AGN-199201

Intervention Type DRUG

1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.

AGN-190584

Intervention Type DRUG

1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.

Interventions

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AGN-199201

1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.

Intervention Type DRUG

AGN-190584

1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.

Intervention Type DRUG

AGN-199201 Vehicle

1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Newport Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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199201-007

Identifier Type: -

Identifier Source: org_study_id