Single Dose Study of Phentolamine Mesylate Eye Drops in Patients With Severe Night Vision Disturbances
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Contrast Sensitivity
研究概览
简要总结
The objectives of this study are:
- To assess the effect of ophthalmic phentolamine mesylate in mesopic conditions on the four endpoints:
- Contrast sensitivity
- Low contrast visual acuity
- Wavefront aberrometry
- Subjective questionnaire
- To assess the safety of ophthalmic phentolamine mesylate
详细描述
Double-masked, placebo-controlled, single-dose Phase 2 study in 24 patients experiencing severe night vision difficulties to evaluate ocular and systemic safety and efficacy following administration of one drop of phentolamine mesylate 1.0% QD in each eye for 1 day.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥ 18 years of age
- •Currently experiencing severe night vision difficulty as reported subjectively
- •At least two patches below the normal range at any two frequencies in Contrast Sensitivity done under mesopic conditions with glare
- •Improvement in low contrast visual acuity (LCVA) in dim light during illumination of contralateral eye
- •Good general health
- •Written informed consent to participate in this trial
- •Ability to comply with all protocol mandated procedures and to attend all scheduled office visits
排除标准
- •Patients with untreated cataracts grades 1-4
- •Patients who wear contact lenses
- •Less than 5 weeks post-refractive surgery (LASIK or PRK)
- •Less than 5 weeks post intraocular lens insertion
- •Low blood pressure (systolic <120 mm Hg or diastolic <80 mm Hg)
- •A history of heart rate abnormalities
- •Administration of any investigational drug within 30 days of study initiation
- •Use of any eye drops with a pharmacologic effect on the pupil within 7 days of Visit 1
- •Use of any systemic alpha adrenergic antagonists (Appendix 1)
- •Known local or systemic hypersensitivity to adrenergic antagonists
- •For women of childbearing potential: currently pregnant or lactating, or unwilling to use birth control during the study
研究组 & 干预措施
Phentolamine Mesylate Ophthalmic Solution 1%
1 drop in each eye (QD) for one day.
干预措施: Phentolamine Mesylate Ophthalmic Solution 1% (Drug)
Phentolamine Mesylate Ophthalmic Solution Vehicle
1 drop in each eye (QD) for one day.
干预措施: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo) (Other)
结局指标
主要结局
Contrast Sensitivity
时间窗: 1 day
Average change in monocular contrast sensitivity scores under mesopic conditions at each of five spatial frequencies with and without glare. The tests were performed in a darkened room using the Optec 6500 instrument (Stereo Optical) using Slides 5-9 (spatial frequencies 1.5 - 18 cycles per degree), with the distance setting at "far", and with the light setting at "night". Subjects were asked to read each slide from left to right indicating if the lines were tilted to the left, the right or straight up and down until they provided 2 consecutive incorrect responses. The total number of correct responses for each slide was recorded.
次要结局
- Self-Reported Vision Quality(1 day)
- Pupil Diameter(1 day)
- Visual Acuity(1 day)