Understanding Quality of Life in Presbyopic Patients Who Are Treated With Qlosi
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Near Visual Acuity Questionnaire-Presbyopia
研究概览
简要总结
The goal of this clinical trial is to determine how Qlosi™ (pilocarpine HCL ophthalmic solution) 0.4%impacts the quality of life of participants with presbyopia by using a battery of validated and investigator-developed instruments
- Improvement in presbyopic symptoms as measured with the Near Activity Visual Questionnaire-Presbyopia (NAVQ-P) when using Qlosi™ at week 4 compared to baseline (continuous variable).
- Improvement in presbyopic symptoms as measured with the Visual Quality of Life with Time Survey (VisQualT) questionnaire when using Qlosi™ at week 4 compared to baseline.
详细描述
This will be a prospective, multi-center, study. Subjects will be treated with Qlosi™ BID OD/OS, and subjects will only be allowed to use reading glasses for urgent work. All subjects will be prescribed a pair of distance spectacles (no near add) at the screening visit. The baseline survey and visual acuity data will be collected at the spectacle dispense visit (outcome measures). The screening visit data will be used as the baseline data for slit-lamp biomicroscope and indirect ophthalmoscopy and not repeated at the dispense visit. The investigators feel that this approach is reasonable because it is unlikely that the slit-lamp biomicroscope and indirect ophthalmoscopy data will change between the screening visit and dispense visit. Distance spectacles will be provided at a dispense visit 1-2 weeks after screening and a logMAR visual acuity of 0.00 or better OD/OS at distance will be confirmed. Subjects will then be instructed to start their treatment. After 4 weeks, subjects will return for an evaluation visit that will occur 4-6 hours after starting treatment for the day. Subjects will then be compensated for their time and exited from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are 45-64 years old (inclusive) at the time of screening.
- •Be able and willing to provide written informed consent and sign a Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed.
- •Be able and willing to follow all instructions and attend study visits.
- •Have text messaging capabilities on their phone.
- •Self-reported complaints of near vision blur when fully corrected at distance.
- •Study confirmed near add that is between +0.75 D to +2.00 D OD/OS (inclusive).
- •Spherical distance prescription between +1.00 D to -4.00 D OD/OS (inclusive).
- •Cylinder power less than or equal to -1.00 D OD/OS.
- •Best-corrected visual acuity (BCVA) at distance of 0.00 logMAR (20/20 Snellen equivalent) or better OD/OS.
排除标准
- •Known hypersensitivity to any ingredient in the study drops.
- •Any active ocular condition that may confound study results (e.g., dry eye, allergy, conjunctivitis, ocular infection).
- •Any use of prescription eye drops 1 week before screening or during the study.
- •Any past use of the study drops.
- •Any contact lens use for the duration of the study.
- •Artificial tears or lubricant eye drops use on the day of or during any study visits.
- •Clinically significant abnormal findings (e.g., central corneal scar) on a slit lamp exam in either eye documented at screening or a known history of a clinically significant slit-lamp finding in either eye that could confound study results.
- •Have had an ocular surgical intervention within 6 months of the screening visit or planned surgical intervention during the study.
- •A female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy.
- •Any visible retinal findings noted upon a dilated fundus examination known to be a risk for use of study treatment (as determined by the investigator).
研究组 & 干预措施
Qlosi
Subjects will be treated with Qlosi™ BID OD/OS, and subjects will only be allowed to use reading glasses for urgent work
干预措施: pilocarpine HCL ophthalmic solution (Drug)
结局指标
主要结局
Near Visual Acuity Questionnaire-Presbyopia
时间窗: 1 month
• Improvement in presbyopic symptoms as measured with the Near Activity Visual Questionnaire-Presbyopia (NAVQ-P) when using Qlosi at week 4 compared to baseline (continuous variable). In which higher scores are better.
次要结局
- Visual Quality of Life with Time Survey (VisQualT)(1 month)
- Text message surveys(1 day, 1 week, 1 month)
- Improvement in overall visual acuity score(1 month)
- Investigator developed survey(1 month)