NCT04024891已完成2 期
Randomized, Cross-Over, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Phentolamine Mesylate Ophthalmic Solution to Reverse Pharmacologically Induced Mydriasis in Normal Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Pupil Diameter (Change From Max)
研究概览
简要总结
The objectives of this study are:
- To evaluate the efficacy of Nyxol (phentolamine mesylate ophthalmic solution 1%) to expedite the reversal of pharmacologic mydriasis
- To evaluate the safety of Nyxol
- To evaluate the effect of Lumify® to suppress conjunctival hyperemia (redness) potentially associated with administration of Nyxol
详细描述
Randomized, 2-arm cross-over, double-masked Phase 2b study in approximately 32 healthy subjects, evaluating safety and efficacy of Nyxol in subjects with pharmacologically induced mydriasis.
At the first visit subjects will be screened for study eligibility.
After screening, eligible subjects will be randomized 1:1 to one of the two treatment sequences:
Treatment sequence 1: Placebo (Visit 1), Nyxol (Visit 2).
Treatment sequence 2: Nyxol (Visit 1), Placebo (Visit 2).
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females ≥ 18 and ≤ 45 years of age with brown irides (irises) only
- •Otherwise healthy and well controlled subjects
- •Able to comply with all protocol mandated procedures and to attend all scheduled office visits
- •Willing to give written informed consent to participate in this study
- •Exclusion Criteria
- •Clinically significant ocular disease as deemed by the Investigator (e.g., cataract, glaucoma, corneal edema, uveitis, severe keratoconjunctivitis sicca) that might interfere with the study
- •Unwilling or unable to discontinue use of contact lenses during treatment visits
- •Ocular trauma, ocular surgery or non-refractive laser treatment within the 6 months prior to screening
- •Ocular medication of any kind within 30 days of screening, with the exception of a) lid scrubs (which may have been used prior to, but not after screening) or b) lubricating drops for dry eye (preservative-free artificial tears), which may be used in between the study treatment days
- •Recent or current evidence of ocular infection or inflammation. Current evidence of clinically significant blepharitis, conjunctivitis, or a history of herpes simplex or herpes zoster keratitis at screening
- •History of diabetic retinopathy
- •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 (e.g., irregularly shaped pupil, neurogenic pupil disorder, iris atrophy, iridotomy)
- •Known allergy or contraindication to any component of the mydriatic agents or the vehicle formulation
- •Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists (e.g., chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure (BP) or heart rate (HR); second- or third-degree heart blockage or Congestive Heart Failure (CHF); severe diabetes)
- •Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, cancer, hepatic, renal, endocrine or cardiovascular disorders) that might interfere with the study
- •Initiation of treatment with or any changes to the current dosage, drug or regimen of any topical or systemic adrenergic or cholinergic drugs up to 7 days prior to screening, or during the study
- •Participation in any investigational study within 30 days prior to screening
- •Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. Acceptable methods include the use of at least one of the following: intrauterine device (IUD), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence. An adult woman is considered to be of childbearing potential unless she is 1 year postmenopausal or 3 months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at Visit 1/Screening and Visit 2 examinations and must intend to not become pregnant during the study
- •Resting heart rate (HR) outside the normal range (50-110 beats per minute) at the Screening Visit. HR may be repeated only once if outside the normal range following at least a 5-minute rest period in the sitting position
- •Hypertension with resting diastolic BP > 105 mmHg or systolic BP > 160 mmHg at the Screening Visit. BP may be repeated only once if outside the specified range following at least a 5-minute rest period in the sitting position
排除标准
- 未提供
研究组 & 干预措施
Phentolamine Mesylate Ophthalmic Solution 1%
Experimental
1 drop in each eye, 1 hour post medically-induced mydriasis
干预措施: Phentolamine Mesylate Ophthalmic Solution 1% (Drug)
Phentolamine Mesylate Ophthalmic Solution Vehicle
Placebo Comparator
1 drop in each eye, 1 hour post medically-induced mydriasis
干预措施: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo) (Other)
结局指标
主要结局
Pupil Diameter (Change From Max)
时间窗: 2 hours
Change in pharmacologically-induced mydriatic (maximum) pupil diameter at 2 hours post-treatment in the study eye.
次要结局
- Pupil Diameter (Change From Max)(30 min, 1 hours, 4 hours, 6 hours)
- Pupil Diameter Return to Baseline(0 min, 1 hour, 2 hours, 4 hours, 6 hours)
- Accommodation Measured by the Near Point Rule (Diopters) (Change From Baseline), Percent With Unchanged Accommodation(0 min, 2 hours, 4 hours)
- Conjunctival Hyperemia (Eye Redness) Assessed Visually With the Brien Holden Vision Institute (Formerly Corneal and Contact Lens Research Unit, or CCLRU) Bulbar Redness Scale (0-3)(0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours)
- Best Corrected Distance Visual Acuity (BCDVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Light Box Chart (Letters) at 4 Meters (Change From Baseline)(0 mins, 30 mins, 1 hour, 2 hours, 4 hours, 6 hours)
- Distance-Corrected Near Visual Acuity (DCNVA) Measured by Standard Reading Card (Original Series Sloan Letter ETDRS Card at 16 Inches, LogMAR Units) (Change From Baseline)(0 mins, 30 mins, 1 hour, 2 hours, 4 hours, 6 hours)
研究者
研究点 (4)
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