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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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

Sponsor: Akron Children's Hospital

Current Primary Outcome: Best Corrected Binocular Visual Acuity [ Time Frame: 1 week ]

Early Treatment of Diabetic Retinopathy Study Vision Testing Protocol of Best corrected Binocular Acuity


Original Primary Outcome:

  • Best Corrected Binocular Visual Acuity [ Time Frame: 1 week ]
    Early Treatment of Diabetic Retinopathy Study Vision Testing Protocol of Best corrected Binocular Acuity
  • Best Corrected Binocular Visual Acuity [ Time Frame: 5 weeks ]
    Early Treatment of Diabetic Retinopathy Study Vision Testing Protocol of Best corrected Binocular Acuity


Current Secondary Outcome: Visual Function [ Time Frame: 5 Days ]

THe Validated Amblyopia and Visual Function Questionnaire will be administered


Original Secondary Outcome: Same as current

Information By: Akron Children's Hospital

Dates:
Date Received: January 21, 2011
Date Started: January 2011
Date Completion:
Last Updated: June 24, 2014
Last Verified: June 2014