A Study to Assess the Impact and Adverse Events of Topical Eyedrops of AGN-190584 on Night-driving Performance in Participants, 40 to 55 Years of Age

Study Overview
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Brief Summary
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The purpose of this study is to evaluate night-driving performance in real-world driving conditions in participants with presbyopia treated with AGN-190584 versus vehicle. Adverse events and change in disease symptoms will be assessed. AGN-190584 is an investigational formulation of pilocarpine for treating symptoms associated with presbyopia as a topical, once-daily eyedrop delivered by a proprietary vehicle. This study consists of two parts. Part 1 consists of Visit 2 and Visit 3, and Part 2 consists of Visit 4 and Visit 5. Approximately half of the participants will receive AGN-190584 at Visit 2 through Visit 3 (Sequence 1 participants) and the remaining participants (Sequence 2 participants) will receive AGN-190584 at Visit 4 through Visit 5. All participants will receive AGN-190584 at home as instructed. Approximately 54 adult participants with presbyopia will be enrolled AT 1 site in Australia. Treatment duration is expected to be no more than 71 days. In Part 1, at Visit 2 (Day 1) and at home as instructed for 7 to 14 days Sequence 1 participants will receive 1 eyedrop of AGN-190584 in each eye and Sequence 2 participants will receive 1 eyedrop of vehicle in each eye. All participants will have a driving assessment at Visit 3 (Day 8 to 15). In Part 2, at Visit 4 (Day 15 to 57) and at home as instructed for 7 to 14 days Sequence 2 participants will receive 1 eyedrop of AGN-190584 in each eye and Sequence 1 participants will receive 1 eyedrop of vehicle in each eye. All participants will have a driving assessment at Visit 5 (Day 22 to 71). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, asking about side effects, and completing questionnaires.

Official Title
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Evaluating the Impact of AGN-190584 on Night-driving Performance

Conditions
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Presbyopia

Intervention / Treatment
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* Drug: AGN-190584


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In good general health at the screening visit, as determined by the investigator from medical history. Subjective complaints of poor near vision that impacts activities of daily living, as defined by at least a moderate impact (score > = 3) on at least 1 question on NEI VFQ-25 Questions 5 to 7 in the main questionnaire or near vision subscale, Questions A3 to A5 in the Appendix of Optional Additional Questions, at the screening visit. Note: Please advise the participant that for this questionnaire they are to interpret the instructions as referring to glasses or contacts they need for seeing objects at a distance (if required), not their reading glasses or bifocals. Photopic, high-contrast, best distance correction in the range of spherical -4.00 D to +1.00 D inclusively and cylinder < = + -2.00 D with photopic at the screening visit and photopic, high-contrast BCDVA of 20/25 or better OD and OS at the screening visit. Photopic, high-contrast HDVA of 20/32 or better OU at screening as well as before and 1 hour after dosing at both driving tests. Only monofocal correction (either spectacles or contact lenses) is allowed for the driving tests. If the participant does not have monofocal correction of 20/32 or better OU, the study site will provide monofocal spectacles. Mesopic, high-contrast DCNVA of 20/40 to 20/100 OD and OS at screening Photopic, high-contrast near visual acuity correctable to 20/40 or better in each eye at the screening visit. Mesopic pupil diameter < 8.0 mm in both eyes at the screening visit. Exclusion Criteria: History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery. Use of any topical ophthalmic medications, including artificial tears other than the study medications during the study. Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes. Corneal abnormalities in either eye that are likely to interfere with visual acuity. Narrow iridocomeal angles, history of angle-closure glaucoma, or previous iridotomy. Diagnosis of any type of glaucoma or ocular hypertension. Females who are pregnant, nursing, or planning a pregnancy during the study. Uncontrolled systemic disease. Severe dry eye disease. History of iris trauma. Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis on screening biomicroscopy.

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGN-190584 Sequence 1<br>AGN-190584 Sequence 1 (Participants will receive AGN-190584 from Visit 2 through Visit 3 followed by Vehicle from Visit 4 through Visit 5). | Drug: AGN-190584<br>* Topical eyedrop<br>|
| Experimental: AGN-190584 Sequence 2<br>AGN-190584 Sequence 2 (Participants will receive Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5). | Drug: AGN-190584<br>* Topical eyedrop<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Composite Driving Z score approximately 1 hour after study intervention instillation | An overall composite driving Z score approximately 1 hour after study intervention instillation will be derived to capture the overall driving performance of each participant compared with the whole group from the following parameters: percent hazards hit, percent sign recognition and recognition distance, pedestrian recognition distances, and percent of time outside of the lane. | Day 8 to Day 71 | 
| Number of Participants with Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The investigator assesses the relationship of each event to the use of the study intervention. A serious adverse event (SAE) is an event that results in death, is life threatening, requires inpatient hospitalization or prolongs an existing hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/ treatment emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of the study drug. | Day -30 to Day 71 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Presbyopia, AGN-190584