A Study of the Concurrent Use of AGN-190584 and AGN-199201 in Participants With Presbyopia

Study Overview
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Brief Summary
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This study will identify the optimum concentrations of AGN-199201 and AGN-190584 when dosed in combination once a day for the improvement of uncorrected near visual acuity in participants with presbyopia (inability to focus on items close-up).

Official Title
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A Phase 2, Multicenter, Double-masked, Randomized, Vehicle-Controlled, Study of the Concurrent Use of AGN-190584 and AGN-199201 in Patients With Presbyopia

Conditions
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Presbyopia

Intervention / Treatment
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* Drug: AGN-199201 ophthalmic solution
* Drug: AGN-190584 ophthalmic solution
* Drug: AGN-190584 vehicle
* Drug: AGN-199201 + AGN-190584 Combination
* Drug: AGN-199201 vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Normal vision at distance, either natural or post corneal laser refractive surgery, with presbyopia in each eye and complaints of poor near vision that impacts activities of daily living. Exclusion Criteria: Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study Corneal abnormalities in either eye that interfere with visual acuity History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery or any intraocular surgery Diagnosis of glaucoma or ocular hypertension.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGN-199201 and AGN-190584 Vehicle<br>Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | Drug: AGN-199201 ophthalmic solution<br>* 1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.<br>Drug: AGN-190584 ophthalmic solution<br>* 1 drop AGN-190584 ophthalmic solution doses A, B and C in the eye.<br>Drug: AGN-190584 vehicle<br>* Vehicle to AGN-190584<br>Drug: AGN-199201 + AGN-190584 Combination<br>* 1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.<br>Drug: AGN-199201 vehicle<br>* Vehicle to AGN-199201<br>|
| Experimental: AGN-199201 and AGN-190584 Dose A<br>Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose A, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | Drug: AGN-199201 ophthalmic solution<br>* 1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.<br>Drug: AGN-190584 ophthalmic solution<br>* 1 drop AGN-190584 ophthalmic solution doses A, B and C in the eye.<br>Drug: AGN-190584 vehicle<br>* Vehicle to AGN-190584<br>Drug: AGN-199201 + AGN-190584 Combination<br>* 1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.<br>Drug: AGN-199201 vehicle<br>* Vehicle to AGN-199201<br>|
| Experimental: AGN-199201 and AGN-190584 Dose B<br>Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose B, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | Drug: AGN-199201 ophthalmic solution<br>* 1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.<br>Drug: AGN-190584 ophthalmic solution<br>* 1 drop AGN-190584 ophthalmic solution doses A, B and C in the eye.<br>Drug: AGN-190584 vehicle<br>* Vehicle to AGN-190584<br>Drug: AGN-199201 + AGN-190584 Combination<br>* 1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.<br>Drug: AGN-199201 vehicle<br>* Vehicle to AGN-199201<br>|
| Experimental: AGN-199201 and AGN-190584 Dose C<br>Participants will receive 5 different treatments as per protocol for 2 days each. Treatment 1: nondominant eye--1 drop AGN-199201 vehicle followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 2: nondominant eye--1 drop AGN-199201 Dose A followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 3: nondominant eye--1 drop AGN-199201 Dose B followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 4: nondominant eye--1 drop AGN-199201 Dose C followed by 1 drop AGN-190584 Dose C, dominant eye--2 drops AGN-190584 vehicle; Treatment 5: nondominant eye--1 drop fixed combination of AGN-199201 and AGN-190584 followed by 1 drop AGN-190584 vehicle, dominant eye--2 drops AGN-190584 vehicle. | Drug: AGN-199201 ophthalmic solution<br>* 1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.<br>Drug: AGN-190584 ophthalmic solution<br>* 1 drop AGN-190584 ophthalmic solution doses A, B and C in the eye.<br>Drug: AGN-190584 vehicle<br>* Vehicle to AGN-190584<br>Drug: AGN-199201 + AGN-190584 Combination<br>* 1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.<br>Drug: AGN-199201 vehicle<br>* Vehicle to AGN-199201<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weighted Average Change From Baseline in Mesopic, High Contrast Uncorrected Near Visual Acuity (UNVA) Letters | 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. | Baseline, Between hour 1 and hour 10 of each of the five 2-day dosing periods |