A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice Daily

Study Overview
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Brief Summary
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Currently available treatments for presbyopia (old eye) include nonsurgical options (spectacles or contact lenses) and surgical options, however, each has its own risks and limitations. The purpose of this study is to evaluate how effective AGN-190584 is in treating presbyopia compared to vehicle (placebo). AGN-190584 is an investigational drug being developed for the treatment of presbyopia. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to vehicle. Around 200 participants age 40-55 years with a diagnosis of presbyopia will be enrolled in the study in approximately 20 sites in the United States. Participants will receive AGN-190584 or vehicle in each eye twice daily for 14 days. There may be additional procedures for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a doctor's office. The effect of the treatment will be checked by medical assessments, vision/eye tests, checking for side effects and completing questionnaires.

Official Title
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A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of BID Dosing of AGN-190584 in Subjects With Presbyopia

Conditions
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Presbyopia

Intervention / Treatment
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* Drug: Pilocarpine HCl
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Objective and subjective evidence of presbyopia. Exclusion Criteria: Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity. Narrow iridocorneal angles (Shaffer grade <=2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy. Diagnosis of any type of glaucoma or ocular hypertension. History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery. Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes.

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 |
| --- | --- |
| Placebo Comparator: Vehicle<br>Participants received vehicle, one drop bilaterally (in each eye), twice daily (BID), with a gap of 6 hours between both doses, for up to 14 days. | Drug: Vehicle<br>* Oxymetazoline HCl and pilocarpine HCl placebo ocular drops.<br>|
| Experimental: AGN-190584<br>AGN-190584 ophthalmic solution, one drop bilaterally (in each eye), BID, with a gap of 6 hours between both doses, for up to 14 days. | Drug: Pilocarpine HCl<br>* Pilocarpine HCl ophthalmic solution 1.25% ocular drops.<br>* Other names: AGN-190584;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Gaining 3 Lines or More in Mesopic, High-Contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) With No More Than 5-Letter Loss in Mesopic Corrected Distance Visual Acuity (CDVA) With the Same Refractive Correction | Visual acuity for near (40 centimeter [cm]) and distance (4 meter [m]) targets were measured in mesopic conditions using an eye chart. High contrast corrected distance visual acuity (CDVA) was assessed binocularly (in each eye) using the provided visual acuity charts for distance vision in a room with mesopic lighting conditions (10 to 11 lux) measured at the target. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who gained 3 lines or more in mesopic, high contrast, binocular DCNVA with no more than 5-letter loss in mesopic CDVA with the same refractive correction was regarded as a responder. A participant with missing data was regarded as a non-responder. | 3 hours after second dose on Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Gaining 3 Lines or More in Photopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Photopic CDVA With the Same Refractive Correction | Visual acuity for near (40 centimeter [cm]) and distance (4 meter [m]) targets were measured in photopic conditions using an eye chart. High contrast corrected distance visual acuity (CDVA) was assessed binocularly (in each eye) using the provided visual acuity charts for distance vision in a room with photopic lighting conditions (≥ 251 lux) measured at the target. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who gained 3 lines or more in photopic, high contrast, binocular DCNVA with no more than 5-letter loss in photopic CDVA with the same refractive correction was regarded as a responder. A participant with missing data was regarded as a non-responder. | 3 hours after second dose on Day 14 | 
| Percentage of Participants Gaining 2 Lines or More in Mesopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Mesopic CDVA With the Same Refractive Correction | Visual acuity for near (40 centimeter [cm]) and distance (4 meter [m]) targets were measured in mesopic conditions using an eye chart. High contrast corrected distance visual acuity (CDVA) was assessed binocularly (in each eye) using the provided visual acuity charts for distance vision in a room with photopic lighting conditions (10 to 11 lux) measured at the target. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who gained 2 lines or more in mesopic, high contrast, binocular DCNVA with no more than 5-letter loss in mesopic CDVA with the same refractive correction was regarded as a responder at that visit/timepoint. A participant with missing data was regarded as a non-responder. | 3 hours after second dose on Day 14 | 
| Percentage of Participants Achieving 20/40 or Better in Mesopic, High-Contrast, Binocular DCNVA With No More Than a 5-Letter Loss in Mesopic CDVA With the Same Refractive Correction | Visual acuity for near (40 cm) target was measured in mesopic conditions using an eye chart. Both near vision and distance vision were measured to evaluate the effect of AGN-190584. A participant who achieved 20/40 or better in mesopic, high contrast, binocular DCNVA with no more than 5-letter loss in mesopic CDVA with the same refractive correction was regarded as a responder at that visit/timepoint. A participant with missing data was regarded as a non-responder. | 3 hours after second dose on Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Presbyopia, AGN-190584, Pilocarpine HCl 1.25%, Old Eye, Aged Eye