NCT07674966已完成1 期
An Investigation of Topical Ophthalmic Low-Dose Atropine on Pupil Size and Accommodation
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Minimum pupil size
研究概览
简要总结
The goal of this clinical study is to learn about the short-term physiological effects of low-dose atropine in healthy volunteers. The study seeks to examine three questions related to low-dose topically applied ophthalmic atropine:
- Does applying two drops of 0.01% atropine sulfate solution cause the same clinical effects as one drop of 0.02% atropine?
- How quickly do the pupil responses and accommodative amplitudes recover following a dose of 0.01% atropine, 0.02% atropine, and 0.05% atropine?
- Does applying a single drop of 0.02% atropine sulfate solution cause the same clinical effects in participants with light vs. dark iris colors? Participants will have their pupil size and accommodative status measured at appropriate intervals to answer the questions above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects may be male or female, of any race, and between 18-40 years old at the time of screening.
- •Patients must have best spectacle corrected visual acuity of at least 0.10 logMAR (20/25) in each eye.
- •Subjects must be willing and able to apply eye drops to their non-dominant eye and to return for all scheduled follow-up visits.
排除标准
- •Subjects with any contraindication to atropine use (as listed on package insert). At the time of this submission, the only contraindication listed is: "Hypersensitivity or allergic reaction to any ingredient in formulation"
- •Subjects using monamine oxidase inhibitors (MAOIs). These are: Isocarboxazid (Marplan), Phenelzine (Nardil), Selegiline (Emsam), and Tranylcypromine (Parnate).
- •Subjects with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
- •Subjects with a history of intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including but not limited to, blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization >1mm from limbus), clinically significant lens opacity, clinical evidence of trauma (including scarring). This includes any patient with open-angle glaucoma, regardless of medication regimen or control. Additionally, any patient with an intra-ocular pressure (IOP) greater than 21 mm Hg at baseline is specifically excluded from eligibility. Subjects with narrow angles (less than Van Herick angle of 3) will also be excluded.
- •Subjects who are pregnant, planning to become pregnant or breastfeeding during the course of the study.
结局指标
主要结局
Minimum pupil size
时间窗: 1-24 hours after drop application
Dynamic pupil responses to a single pulse of light were measured 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours after instilling the drop(s). The smallest pupil size (maximum pupil restriction) was used as the primary outcome measure.
次要结局
- Accommodative Amplitude(1-24 hours after drop application)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
A Clinical Study Evaluating Licaminlimab for Dry Eye DiseaseDry Eye Disease (DED)NCT07548632Oculis160
Enrolling By Invitation
不适用
Effect of Low-Level Light Therapy on Ocular Surface Parameters in Patients With Graves DiseaseNCT07332988Grigore T. Popa University of Medicine and Pharmacy30
尚未招募
3 期
Efficacy and Safety of FID 123472 Ophthalmic Solution for Ocular Redness in AdultsOcular HyperemiaNCT07531043Alcon Research230
尚未招募
不适用
Comparing topical use of 0.25% Amorolfine cream with 1% Luliconazole cream for Ringworm infectionCTRI/2025/07/090086Government Medical College Nagpur60
尚未招募
不适用
To assess the effect of pre-operative antibiotic eye drops on conjuntival bacterial flora in preoperative cataract surgery patientsCTRI/2025/04/084740Divya Elizabeth Varghese120