A Phase 3 Study of the Safety and Efficacy of 1% and 2% Pilocarpine Ophthalmic Solutions Administered With the Optejet® Microdose Dispenser for Temporary Improvement of Near Vision in Adults With Presbyopia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 9
- 主要终点
- Proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA)
研究概览
简要总结
Volunteer participants are evaluated for eligibility during a Screening Visit; those meeting study inclusion/exclusion criteria are scheduled for 3 treatment visits. At each treatment visit, 1 of the 3 study solutions is self-administered to both eyes. Afterwards, efficacy and safety assessments are performed over a 3-hour period.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Poor near vision impacting daily living that requires near correction
- •Best-corrected distance visual acuity (BCDVA) of 0.0 logMar or better
- •Manifest refraction spherical equivalent ≥ -2.00 Diopters (D) and ≤ +2.00 D
- •Monocular DCNVA between 0.4 and 0.7 logMAR, inclusive
排除标准
- •Diagnosis of glaucoma or ocular hypertension
- •Narrow iridocorneal angles
- •History of intraocular surgery, refractive surgery, laser treatment, or iris surgery
- •Clinically significant abnormality of cornea, lens, retina, ciliary body, or iris
- •Presence/history of a severe/serious ocular condition or any other unstable medical condition
- •Presence or history of manifest strabismus, amblyopia, or nystagmus
- •Current active eye disease for which topical or systemic ophthalmic medication is necessary, except for dry eye syndrome managed using artificial tears
- •Clinically significant external ocular inflammation within 30 days of Screening Visit
- •Current use or history of rigid gas permeable (RGP) contact lens use within 30 days of Screening Visit
- •Known pilocarpine allergy or contraindication to use of pilocarpine
- •Presence or history of congenital heart anomaly, valve disease, or other cardiac disease
- •Disabling arthritis or limited motor coordination that would limit the subject's ability to self-administer study solution using the Optejet
研究组 & 干预措施
Pilocarpine 1% Solution
1% pilocarpine ophthalmic solution administered with the Optejet dispenser
干预措施: Pilocarpine Ophthalmic (Drug)
Pilocarpine 2% Solution
2% pilocarpine ophthalmic solution administered with the Optejet dispenser
干预措施: Pilocarpine Ophthalmic (Drug)
Placebo Solution
Placebo ophthalmic solution administered with the Optejet dispenser
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA)
时间窗: 120 minutes post-dosing
The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA as compared to baseline.
次要结局
未报告次要终点