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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01312402
Recruitment Status : Completed
First Posted : March 10, 2011
Last Update Posted : June 25, 2014
Information provided by (Responsible Party):
Richard W. Hertle, Akron Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Infantile Nystagmus Syndrome Drug: topical brinzolamide 1% in 5mL ophthalmic medication Drug: Placebo in 5 mL dispenser Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topical Brinzolamide Ophthalmic Suspension Versus Placebo in the Treatment of Infantile Nystagmus Syndrome
Study Start Date : January 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Topical Brinzolamide (Azopt)
ophthalmic drop given three times a day
Drug: topical brinzolamide 1% in 5mL ophthalmic medication
1 drop three times a day in both eyes on days 2,3 and 4
Other Name: Azopt 1% in 5 mL

Placebo Comparator: placebo ophthalmic drop in 5 mL solution
masked non-active eye drop (absence of Brinzolamide)
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

Primary Outcome Measures :
  1. Best Corrected Binocular Visual Acuity [ Time Frame: 1 week ]
    Early Treatment of Diabetic Retinopathy Study Vision Testing Protocol of Best corrected Binocular Acuity

Secondary Outcome Measures :
  1. Visual Function [ Time Frame: 5 Days ]
    THe Validated Amblyopia and Visual Function Questionnaire will be administered

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01312402

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United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308
Sponsors and Collaborators
Akron Children's Hospital
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Principal Investigator: Richard W. Hertle, M.D. Akron Children's Hospital
Principal Investigator: Dongsheng Yang, Ph.D. Akron Children's Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Richard W. Hertle, MD, Akron Children's Hospital Identifier: NCT01312402    
Other Study ID Numbers: 101109
First Posted: March 10, 2011    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Nystagmus, Pathologic
Pathologic Processes
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action