NCT01312402

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Akron Children's Hospital · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Infantile Nystagmus Syndrome

Interventions

Type	Name	Description
DRUG	topical brinzolamide 1% in 5mL ophthalmic medication	1 drop three times a day in both eyes on days 2,3 and 4
DRUG	Placebo in 5 mL dispenser	Placebo ophthalmic solution in 5 mL dispenser; 1 drop three times a day on days 2,3 and 4

Timeline

• Start date: 2011-01-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2011-03-10
• Last updated: 2014-06-25

Locations

1 site across 1 country: United States