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

This study has been completed.
Information provided by (Responsible Party):
Richard W. Hertle, Akron Children's Hospital Identifier:
First received: January 21, 2011
Last updated: June 24, 2014
Last verified: June 2014
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 Intervention Phase
Infantile Nystagmus Syndrome Drug: topical brinzolamide 1% in 5mL ophthalmic medication Drug: Placebo in 5 mL dispenser Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Richard W. Hertle, Akron Children's Hospital:

Primary Outcome Measures:
  • 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:
  • Visual Function [ Time Frame: 5 Days ]
    THe Validated Amblyopia and Visual Function Questionnaire will be administered

Enrollment: 5
Study Start Date: January 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01312402

United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308
Sponsors and Collaborators
Akron Children's Hospital
Principal Investigator: Richard W. Hertle, M.D. Akron Children's Hospital
Principal Investigator: Dongsheng Yang, Ph.D. Akron Children's Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Richard W. Hertle, MD, Akron Children's Hospital Identifier: NCT01312402     History of Changes
Other Study ID Numbers: 101109
Study First Received: January 21, 2011
Last Updated: June 24, 2014

Additional relevant MeSH terms:
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 processed this record on September 21, 2017