NCT05114486已完成3 期
A Phase 3 Study of the Safety and Efficacy of 2% Pilocarpine Ophthalmic Spray Administered With the Optejet® Microdose Dispenser for Temporary Improvement of Near Vision in Adults With Presbyopia
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 18
- 主要终点
- Proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA) with ≤ 5 letter loss in mesopic, high contrast, binocular distance visual acuity (DVA)
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 2 treatment visits. At each treatment visit, 1 of the 2 study treatments 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 55 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
- •In need of near addition power < +2.00 D to achieve BCNVA of 0.0 logMAR
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
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) with ≤ 5 letter loss in mesopic, high contrast, binocular distance visual acuity (DVA)
时间窗: 120 minutes post-dosing
The proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular DCNVA with ≤ 5 letter loss DVA as compared to baseline.
次要结局
未报告次要终点
研究者
研究点 (18)
Loading locations...
相似试验
已完成
3 期
Safety & Efficacy of Pilocarpine Eye Solutions for Temporary Improvement of Near Vision in Presbyopic AdultsPresbyopiaNCT04657172Eyenovia Inc.84
终止
不适用
Evaluation of the Safety and Efficacy of Corneal Cross Linking for the Treatment of Myopia.MyopiaNCT02872766University Hospital, Toulouse24
进行中（未招募）
不适用
Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm InfantsEUCTR2006-002898-47-ESGlaxoSmithKline S.A.300
进行中（未招募）
1 期
A phase IIIb open study to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine in preterm infants as a 3-dose primary immunisation course during the first 6 months of life - 10PN-PD-DIT-015Three dose primary vaccination of preterm infants between 8-16 weeks (56-118 days) of age at the time of first vaccination against Streptococcus pneumoniae.EUCTR2006-002898-47-GRGlaxoSmithKline Biologicals286
已完成
3 期
Effectiveness and Safety of EN3835 in the Treatment of Cellulite in WomenEdematous Fibrosclerotic Panniculopathy (Cellulite)NCT03446781Endo Pharmaceuticals422