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

NCT01312402 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2014-06-25

No results posted yet for this study

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.

Conditions

  • Infantile Nystagmus Syndrome

Interventions

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

Sponsors & Collaborators

  • Akron Children's Hospital

    lead OTHER

Principal Investigators

  • Richard W. Hertle, M.D. · Akron Children's Hospital

  • Dongsheng Yang, Ph.D. · Akron Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01312402 on ClinicalTrials.gov