Topical Brinzolamide Ophthalmic Suspension Versus Placebo in the Treatment of Infantile Nystagmus Syndrome - Full Text View

Purpose

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Brinzolamide

Genetic and Rare Diseases Information Center resources: Ocular Motility Disorders Motor Neuro-ophthalmic Disorders

U.S. FDA Resources

Further study details as provided by Akron Children's Hospital:

Primary Outcome Measures:

Best Corrected Binocular Visual Acuity [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
Early Treatment of Diabetic Retinopathy Study Vision Testing Protocol of Best corrected Binocular Acuity

Secondary Outcome Measures:

Visual Function [ Time Frame: 5 Days ] [ Designated as safety issue: No ]
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

Eligibility


Ages Eligible for Study:	12 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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 ClinicalTrials.gov identifier: NCT01312402

Locations


United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308

Sponsors and Collaborators

Akron Children's Hospital

Investigators


Principal Investigator:	Richard W. Hertle, M.D.	Akron Children's Hospital
Principal Investigator:	Dongsheng Yang, Ph.D.	Akron Children's Hospital

More Information

Publications:

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.

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.

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Richard W. Hertle, MD, Akron Children's Hospital
ClinicalTrials.gov Identifier:	NCT01312402 History of Changes
Other Study ID Numbers:	101109
Study First Received:	January 21, 2011
Last Updated:	June 24, 2014
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Syndrome Nystagmus, Pathologic Disease Pathologic Processes Ocular Motility Disorders Cranial Nerve Diseases	Nervous System Diseases Eye Diseases Brinzolamide Carbonic Anhydrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016