A Multi-Center, Double-Masked, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Fixed Combination Phenylephrine 2.5%-Tropicamide 1% Ophthalmic Solution Administered With a Microdose Dispenser for Dilation of the Pupil
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Change in Pupil Diameter From Baseline
研究概览
简要总结
This study evaluated pupil dilation after administration of fixed combination tropicamide-phenylephrine (TR/PH) vs. placebo. Participants attended 3 visits. At each visit, after baseline measurements, either the study drug or placebo was administered to both eyes, then pupil dilation and safety assessments were performed at specific time intervals.
详细描述
Volunteer participants were screened for study eligibility during a Screening Visit and enrolled after signing the study-specific informed consent form. Subjects meeting all inclusion/exclusion criteria were scheduled for 3 treatment visits, which were at least 2 days, but no more than 7 days apart. At each treatment visit, baseline measurements were taken, then either the study drug or placebo was administered to both eyes. Afterwards, efficacy and safety assessments were performed at 20, 35, 50, 65, 80, 120, and 180 minutes. Participants' treatment assignments for each treatment visit were equally randomized using 1 of 2 sequences - ABB or BAA, where A was the study drug and B was the placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
There were no differences in the presentation of study treatment administered and all study personnel conducting ophthalmic assessments after study treatment administration were masked to treatment assignment.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to provide written consent and return for all study visits
- •Photopic pupil diameter <= 3.5 mm in each eye
排除标准
- •Allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride
- •History of benign prostatic hyperplasia
- •Use of a benzodiazepine, monoamine oxidase inhibitor, tricyclic antidepressant, anticonvulsant, or cholinergic drug
- •History of closed-angle glaucoma
- •Anatomically narrow anterior chamber angles
- •Ocular surgery or laser treatment of any kind
- •History of chronic or acute uveitis
- •History of traumatic iritis or hyphema
- •History of traumatic mydriasis or angle recession
- •History of heterochromia
- •Irregularly-shaped pupil secondary to ocular trauma or congenital defect.
- •History of neurogenic pupil disorder
- •History of anterior chamber intraocular lens (IOL) or iris-fixated IOL
- •History of iris surgery, iris atrophy, or iris-cornea apposition/touch
- •Unwilling or unable to discontinue use of contact lenses at treatment visits.
- •Current active eye disease for which topical or systemic ophthalmic medication is necessary, except for dry eye disease managed using artificial tears.
- •Presence of a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment and/or follow-up
- •Pregnancy or lactation
研究组 & 干预措施
1-TR/PE, 2-Placebo, 3-Placebo
Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the designated treatment in each eye.
干预措施: Tropicamide/Phenylephrine ophthalmic solution (TR/PE) (Drug)
1-TR/PE, 2-Placebo, 3-Placebo
Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the designated treatment in each eye.
干预措施: Placebo (Drug)
1-Placebo, 2-Placebo, 3-TR/PE
Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the designated treatment in each eye.
干预措施: Tropicamide/Phenylephrine ophthalmic solution (TR/PE) (Drug)
1-Placebo, 2-Placebo, 3-TR/PE
Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the designated treatment in each eye.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Pupil Diameter From Baseline
时间窗: 35 minutes after initial dose
Difference in 35-minute pupil diameter vs. baseline measured using pupillometry in highly photopic conditions. Pupil diameter is reported in millimeters. For the change in pupil diameter, larger measurements indicate a better outcome.
次要结局
未报告次要终点