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

Allergan

Status and phase: Completed; Phase 2

Conditions: Presbyopia

Treatments: Drug: AGN-199201; Drug: AGN-190584; Drug: AGN-199201 Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02197806

199201-007

Details and patient eligibility

About

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).

Enrollment: 65 patients

Sex: All

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 4 patient groups

AGN-199201

Experimental 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.

Treatment:

Drug: AGN-199201 Vehicle

Drug: AGN-199201

AGN-190584

Experimental group

Description:

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.

Treatment:

Drug: AGN-199201 Vehicle

Drug: AGN-190584

AGN-199201 + AGN-190584 in One Eye

Experimental group

Description:

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.

Treatment:

Drug: AGN-199201 Vehicle

Drug: AGN-190584

Drug: AGN-199201

AGN-199201 + AGN-190584 in Both Eyes

Experimental group

Description:

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.

Treatment:

Drug: AGN-190584

Drug: AGN-199201