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

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ClinicalTrials.gov Identifier: NCT01312402
Recruitment Status : Completed
First Posted : March 10, 2011
Last Update Posted : June 25, 2014
Sponsor:
Information provided by (Responsible Party):
Richard W. Hertle, Akron Children's Hospital

Tracking Information
First Submitted Date  ICMJE January 21, 2011
First Posted Date  ICMJE March 10, 2011
Last Update Posted Date June 25, 2014
Study Start Date  ICMJE January 2011
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
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 Measures  ICMJE
 (submitted: March 9, 2011)
  • 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
Change History Complete list of historical versions of study NCT01312402 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2011)
Visual Function [ Time Frame: 5 Days ]
THe Validated Amblyopia and Visual Function Questionnaire will be administered
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Brinzolamide Ophthalmic Suspension Versus Placebo in the Treatment of Infantile Nystagmus Syndrome
Official Title  ICMJE 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 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
Study Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Infantile Nystagmus Syndrome
Intervention  ICMJE
  • 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
  • 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
Study Arms
  • Active Comparator: Topical Brinzolamide (Azopt)
    ophthalmic drop given three times a day
    Intervention: Drug: topical brinzolamide 1% in 5mL ophthalmic medication
  • Placebo Comparator: placebo ophthalmic drop in 5 mL solution
    masked non-active eye drop (absence of Brinzolamide)
    Intervention: Drug: Placebo in 5 mL dispenser
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2011)
5
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01312402
Other Study ID Numbers  ICMJE 101109
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Richard W. Hertle, Akron Children's Hospital
Study Sponsor  ICMJE Akron Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard W. Hertle, M.D. Akron Children's Hospital
Principal Investigator: Dongsheng Yang, Ph.D. Akron Children's Hospital
PRS Account Akron Children's Hospital
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP