Topical Brinzolamide Ophthalmic Suspension Versus Placebo in the Treatment of Infantile Nystagmus Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Best Corrected Binocular Visual Acuity
研究概览
简要总结
This study is a prospective, single crossover, double-masked, controlled clinical trial that will use topical brinzolamide (Azopt)ophthalmic medication to try to improve the nystagmus and visual consequences of nystagmus in patients with infantile nystagmus syndrome (INS). Subjects will undergo a clinical exam, questionnaire and eye movement recordings on day 1 and then receive either topical Azopt or placebo three times a day in both eyes for days 2,3 and 4 followed on the morning of day 5 by a repeat clinical exam, questionnaire and eye movement recordings. After at least one week, this protocol is repeated with the crossover regimen being taken by the subject. One week after all medications are discontinued, another clinical exam is done before study discharge. The hypothesis is that nystagmus and associated visual symptoms will be improved while on the Azopt compared to the placebo. There will be a total of 5 visits over a 1-2 month period.
详细描述
5 subjects are expected to be enrolled in the study. Each subject will be in the study for approximately 1 month.
Efficacy will be assessed by:
- ETDRS Visual Acuity Testing of Binocular Best Corrected Visual Acuity In The Nystagmus Null Zone
- The Validated Amblyopia & Strabismus Ocular Motor Questionnaire
- Eye Movement Recording Data Analysis of The Nystagmus Waveform
Safety will be evaluated by:
- Ocular signs and symptoms
- Visual acuity (uncorrected and best corrected)
- Slit lamp exam and Intraocular Pressure
- Systemic signs and symptoms
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
- 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
- 否
入选标准
- •Age; greater than 12 years old and able to cooperate for full study protocol
- •Subject able to understand and sign informed consent
- •Subject able to participate in complete ophthalmic and ocular motility evaluation
- •Subjects with Infantile Nystagmus Syndrome diagnosed by clinical evaluation and eye movement recordings
- •Best-binocular visual acuity in null position 20/50 to 20/200 inclusive using ATS or ETDRS vision testing
- •Subject/family able and willing to make the required study visits
- •No previous ophthalmic treatment for nystagmus other than for refractive error
排除标准
- •Any current use of systemic or topical medications (traditional or non-traditional)
- •History of ocular surgery, trauma or chronic ocular disease other than amblyopia
- •Systemic diseases requiring medication or other treatments that are known to affect the ocular motor system (e.g., depression, seizure disorders, psychosis)
- •Behavioral or neurological disorders which interfere with the study
- •Physical or mental impairment precluding study compliance
- •Participation in any study involving an IND investigational drug within the past year
- •Individual (female) is pregnant, nursing or planning a pregnancy (The safety of Azopt for use during pregnancy has NOT been determined.)
- •Periodicity or aperiodicity of INS present on eye movement recordings
- •Allergy to sulfa or other components of Azopt solution
研究组 & 干预措施
Topical Brinzolamide (Azopt)
ophthalmic drop given three times a day
干预措施: topical brinzolamide 1% in 5mL ophthalmic medication (Drug)
placebo ophthalmic drop in 5 mL solution
masked non-active eye drop (absence of Brinzolamide)
干预措施: Placebo in 5 mL dispenser (Drug)
结局指标
主要结局
Best Corrected Binocular Visual Acuity
时间窗: 1 week
Early Treatment of Diabetic Retinopathy Study Vision Testing Protocol of Best corrected Binocular Acuity
次要结局
- Visual Function(5 Days)
研究者
Richard W. Hertle
MD
Akron Children's Hospital