Randomized, Parallel Arm, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Healthy Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 12
- 主要终点
- Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline
研究概览
简要总结
The objectives of this study are:
- To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically-induced mydriasis across multiple mydriatic agents with an emphasis on phenylephrine
- To evaluate the efficacy of Nyxol to return subjects to baseline accommodation after worsening (with cycloplegic agents tropicamide and Paremyd)
- To evaluate the safety of Nyxol
- To evaluate any additional benefits of the reversal of pharmacologically-induced mydriasis
详细描述
A randomized, parallel arm, double-masked, placebo-controlled Phase 3 study in at least 168 randomized subjects (160 completed), evaluating the safety and efficacy of Nyxol in subjects with pharmacologically-induced mydriasis.
Following the successful completion of screening, each subject will be stratified by eye color and then simultaneously be randomized to mydriatic agent (unmasked) and treatment (masked).
Treatment randomization will be 1:1, Nyxol or placebo (vehicle).
Stratification by iris color will be 1:1, light or dark irides.
The mydriatic agent randomization will be 3:1:1 (2.5% phenylephrine, 1% tropicamide, and Paremyd). That is, approximately 60% of the randomized subjects will receive one drop of 2.5% phenylephrine 1 hour before treatment (96 completed subjects), approximately 20% will receive one drop of 1% tropicamide 1 hour before treatment (32 completed subjects), and approximately 20% will receive Paremyd 1 hour before treatment (32 completed subjects).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females ≥ 12 years of age
- •Otherwise healthy and well controlled subjects
排除标准
- •Ophthalmic (in either eye):
- •Clinically significant ocular disease as deemed by the Investigator that might interfere with the study
- •Unwilling or unable to discontinue use of contact lenses at screening until study completion
- •Unwilling or unable to suspend use of topical medication at screening until study completion
- •Ocular trauma, ocular surgery or non-refractive laser treatment within the 6 months prior to screening
- •Use of any topical prescription or over-the-counter (OTC) ophthalmic medications of any kind within 7 days of screening
- •Recent or current evidence of ocular infection or inflammation in either eye
- •History of diabetic retinopathy or diabetic macular edema
- •Closed or very narrow angles that in the Investigator's opinion are potentially occludable if the subject's pupil is dilated
- •History of any traumatic (surgical or nonsurgical) or non-traumatic condition affecting the pupil or iris
- •Known allergy or contraindication to any component of the mydriatic agents or the vehicle formulation
- •History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal
- •Known hypersensitivity or contraindication to α- and/or β adrenoceptor antagonists.
- •Clinically significant systemic disease that might interfere with the study
- •Initiation of treatment with or any changes to the current dosage, drug or regimen of any systemic adrenergic or cholinergic drugs within 7 days prior to screening, or during the study
- •Participation in any investigational study within 30 days prior to screening
- •Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
- •Resting HR outside the normal range (50-110 beats per minute)
- •Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg
研究组 & 干预措施
Phentolamine Ophthalmic Solution 0.75%
2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
干预措施: Phentolamine Ophthalmic Solution 0.75% (Drug)
Phentolamine Ophthalmic Solution Vehicle
2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
干预措施: Phentolamine Ophthalmic Solution Vehicle (Placebo) (Other)
结局指标
主要结局
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline
时间窗: 90 minutes
Percentage of subjects' study eyes returning to less than or equal to 0.2 mm from baseline pupil diameter
次要结局
- Percent of Subjects' Study Eyes Pupil Diameter Returning to Baseline(up to 24 hours)
- Pupil Diameter (Change From Max)(up to 24 hours)
- Percent of Subjects With Unchanged Accommodation From Baseline(up to 6 hours)