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

Primary Purpose

Infantile Nystagmus Syndrome

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
topical brinzolamide 1% in 5mL ophthalmic medication
Placebo in 5 mL dispenser
Sponsored by
Akron Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infantile Nystagmus Syndrome

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Akron Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Topical Brinzolamide (Azopt)

placebo ophthalmic drop in 5 mL solution

Arm Description

ophthalmic drop given three times a day

masked non-active eye drop (absence of Brinzolamide)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Visual Function
THe Validated Amblyopia and Visual Function Questionnaire will be administered

Full Information

First Posted
January 21, 2011
Last Updated
June 24, 2014
Sponsor
Akron Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01312402
Brief Title
Topical Brinzolamide Ophthalmic Suspension Versus Placebo in the Treatment of Infantile Nystagmus Syndrome
Official Title
Topical Brinzolamide Ophthalmic Suspension Versus Placebo in the Treatment of Infantile Nystagmus Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akron Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Nystagmus Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topical Brinzolamide (Azopt)
Arm Type
Active Comparator
Arm Description
ophthalmic drop given three times a day
Arm Title
placebo ophthalmic drop in 5 mL solution
Arm Type
Placebo Comparator
Arm Description
masked non-active eye drop (absence of Brinzolamide)
Intervention Type
Drug
Intervention Name(s)
topical brinzolamide 1% in 5mL ophthalmic medication
Other Intervention Name(s)
Azopt 1% in 5 mL
Intervention Description
1 drop three times a day in both eyes on days 2,3 and 4
Intervention Type
Drug
Intervention Name(s)
Placebo in 5 mL dispenser
Intervention Description
Placebo ophthalmic solution in 5 mL dispenser; 1 drop three times a day on days 2,3 and 4
Primary Outcome Measure Information:
Title
Best Corrected Binocular Visual Acuity
Description
Early Treatment of Diabetic Retinopathy Study Vision Testing Protocol of Best corrected Binocular Acuity
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Visual Function
Description
THe Validated Amblyopia and Visual Function Questionnaire will be administered
Time Frame
5 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard W. Hertle, M.D.
Organizational Affiliation
Akron Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dongsheng Yang, Ph.D.
Organizational Affiliation
Akron Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12076015
Citation
Dell'Osso LF, Jacobs JB. An expanded nystagmus acuity function: intra- and intersubject prediction of best-corrected visual acuity. Doc Ophthalmol. 2002 May;104(3):249-76. doi: 10.1023/a:1015299930849.
Results Reference
background
PubMed Identifier
14597515
Citation
Hertle RW, Dell'Osso LF, FitzGibbon EJ, Thompson D, Yang D, Mellow SD. Horizontal rectus tenotomy in patients with congenital nystagmus: results in 10 adults. Ophthalmology. 2003 Nov;110(11):2097-105. doi: 10.1016/S0161-6420(03)00802-9.
Results Reference
background
PubMed Identifier
15629289
Citation
Hertle RW, Anninger W, Yang D, Shatnawi R, Hill VM. Effects of extraocular muscle surgery on 15 patients with oculo-cutaneous albinism (OCA) and infantile nystagmus syndrome (INS). Am J Ophthalmol. 2004 Dec;138(6):978-87. doi: 10.1016/j.ajo.2004.07.029.
Results Reference
background
PubMed Identifier
15616501
Citation
Hertle RW, Dell'Osso LF, FitzGibbon EJ, Yang D, Mellow SD. Horizontal rectus muscle tenotomy in children with infantile nystagmus syndrome: a pilot study. J AAPOS. 2004 Dec;8(6):539-48. doi: 10.1016/j.jaapos.2004.08.005.
Results Reference
background
PubMed Identifier
16799026
Citation
Jacobs JB, Dell'Osso LF, Hertle RW, Acland GM, Bennett J. Eye movement recordings as an effectiveness indicator of gene therapy in RPE65-deficient canines: implications for the ocular motor system. Invest Ophthalmol Vis Sci. 2006 Jul;47(7):2865-75. doi: 10.1167/iovs.05-1233.
Results Reference
background
PubMed Identifier
19458334
Citation
Jacobs JB, Dell'Osso LF, Wang ZI, Acland GM, Bennett J. Using the NAFX to measure the effectiveness over time of gene therapy in canine LCA. Invest Ophthalmol Vis Sci. 2009 Oct;50(10):4685-92. doi: 10.1167/iovs.09-3387. Epub 2009 May 20.
Results Reference
background
PubMed Identifier
25336575
Citation
Hertle RW, Yang D, Adkinson T, Reed M. Topical brinzolamide (Azopt) versus placebo in the treatment of infantile nystagmus syndrome (INS). Br J Ophthalmol. 2015 Apr;99(4):471-6. doi: 10.1136/bjophthalmol-2014-305915. Epub 2014 Oct 21.
Results Reference
derived

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

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