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

Study Overview
=================
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).

Conditions
-----------------
Presbyopia

Intervention / Treatment
-----------------
* Drug: AGN-199201
* Drug: AGN-190584
* Drug: AGN-199201 Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGN-199201<br>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<br>* 1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.<br>Drug: AGN-199201 Vehicle<br>* 1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.<br>|
| Experimental: AGN-190584<br>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<br>* 1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.<br>Drug: AGN-199201 Vehicle<br>* 1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.<br>|
| Experimental: AGN-199201 + AGN-190584 in One Eye<br>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<br>* 1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.<br>Drug: AGN-190584<br>* 1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.<br>Drug: AGN-199201 Vehicle<br>* 1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.<br>|
| Experimental: AGN-199201 + AGN-190584 in Both Eyes<br>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<br>* 1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.<br>Drug: AGN-190584<br>* 1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye | 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. | Baseline, Day 3 |