Evaluating the Impact of AGN-190584 on Night-driving Performance
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Overall Composite Driving Z Score Approximately 1 Hour After Study Intervention Instillation
研究概览
简要总结
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 crossover 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
AGN-190584 Sequence 1
AGN-190584 Sequence 1 (Participants will receive AGN-190584 from Visit 2 through Visit 3 followed by Vehicle from Visit 4 through Visit 5).
干预措施: AGN-190584 (Drug)
AGN-190584 Sequence 1
AGN-190584 Sequence 1 (Participants will receive AGN-190584 from Visit 2 through Visit 3 followed by Vehicle from Visit 4 through Visit 5).
干预措施: Vehicle (Drug)
AGN-190584 Sequence 2
AGN-190584 Sequence 2 (Participants will receive Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5).
干预措施: AGN-190584 (Drug)
AGN-190584 Sequence 2
AGN-190584 Sequence 2 (Participants will receive Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5).
干预措施: Vehicle (Drug)
结局指标
主要结局
Overall Composite Driving Z Score Approximately 1 Hour After Study Intervention Instillation
时间窗: One hour after study intervention instillation at Visit 3 (Day 8 to 15) and at Visit 5 (Day 22 to 71)
An overall composite driving Z-score approximately 1 hour after study intervention instillation was derived to capture the overall driving performance of each participant compared with the whole group for the following parameters: percent hazards hit, percent sign recognition and recognition distance, pedestrian recognition distances, and percent of time outside of the lane. For each participant, the Z-score for each task of the driving test was the difference between his/her value and mean value of the assessments of all participants from the pooled data of both periods combined, divided by the standard deviation of all corresponding assessment values. Because a lower percentage of hazards hit, lower percentage of time outside of the driving lane, and a shorter lap duration indicate better driving performance, the Z-scores of these components were reversed (multiplied by -1) before computing the overall composite driving Z-score. A higher Z-score indicates better driving performance.
Number of Participants With Adverse Events
时间窗: Enrollment to Day 71
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.
次要结局
未报告次要终点