A Safety, Efficacy and Pharmacokinetic Study of AGN-199201 and AGN-190584 in Patients With Presbyopia

Study Overview
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Brief Summary
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This is a safety, efficacy and pharmacokinetics study of the fixed combination of AGN-199201 and AGN-190584 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, Parallel-Group Study Evaluating the Safety, Efficacy, and Pharmacokinetics of the Fixed Combination of AGN-199201 and AGN-190584 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-199201 Vehicle
* Drug: AGN-190584 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: 55 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Vehicle Control<br>Vehicle dosed in both eyes administered once daily during office visits 1 through 5. | Drug: AGN-199201 Vehicle<br>* Vehicle to AGN-199201<br>Drug: AGN-190584 Vehicle<br>* Vehicle to AGN-190584<br>|
| Experimental: Cohort 2: AGN-199201 Dose A and AGN-190584 Dose A<br>Fixed combinations of AGN-199201 Dose A and AGN-190584 Dose A dosed in both eyes administered once daily during office visits 1 through 5. | 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 of AGN-190584 ophthalmic solution Doses A, B, C in the eye.<br>|
| Experimental: Cohort 3: AGN-199201 Dose B and AGN-190584 Dose B<br>Fixed combinations of AGN-199201 Dose B and AGN-190584 Dose B dosed in both eyes administered once daily during office visits 1 through 5. | 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 of AGN-190584 ophthalmic solution Doses A, B, C in the eye.<br>|
| Experimental: Cohort 4: AGN-199201 Dose C and AGN-190584 Dose C<br>Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in both eyes administered once daily during office visits 1 through 5. | 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 of AGN-190584 ophthalmic solution Doses A, B, C in the eye.<br>|
| Experimental: Cohort 5: Vehicle, AGN-199201 Dose C and AGN-190584 Dose C<br>Dominant eye dosed with Vehicle. Fixed combinations of AGN-199201 Dose C and AGN-190584 Dose C dosed in nondominant eye. Treatment administered once daily during office visits 1 through 5. | 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 of AGN-190584 ophthalmic solution Doses A, B, C in the eye.<br>Drug: AGN-199201 Vehicle<br>* Vehicle to AGN-199201<br>Drug: AGN-190584 Vehicle<br>* Vehicle to AGN-190584<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 Uncorrected Near Visual Acuity (UNVA) Letters in the Nondominant 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. | Baseline, Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs) | A Treatment Emergent Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded. | up to 65 days |