Topical Brinzolamide Ophthalmic Suspension Versus Placebo in the Treatment of Infantile Nystagmus Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Topical Brinzolamide Ophthalmic Suspension Versus Placebo in the Treatment of Infantile Nystagmus Syndrome

Conditions
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Infantile Nystagmus Syndrome

Intervention / Treatment
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* Drug: topical brinzolamide 1% in 5mL ophthalmic medication
* Drug: Placebo in 5 mL dispenser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical Brinzolamide (Azopt)<br>ophthalmic drop given three times a day | Drug: topical brinzolamide 1% in 5mL ophthalmic medication<br>* 1 drop three times a day in both eyes on days 2,3 and 4<br>* Other names: Azopt 1% in 5 mL;|
| Placebo Comparator: placebo ophthalmic drop in 5 mL solution<br>masked non-active eye drop (absence of Brinzolamide) | Drug: Placebo in 5 mL dispenser<br>* Placebo ophthalmic solution in 5 mL dispenser; 1 drop three times a day on days 2,3 and 4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Binocular Visual Acuity | Early Treatment of Diabetic Retinopathy Study Vision Testing Protocol of Best corrected Binocular Acuity | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Function | THe Validated Amblyopia and Visual Function Questionnaire will be administered | 5 Days |