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
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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 |
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 : | 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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Topical Brinzolamide (Azopt)
ophthalmic drop given three times a day
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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)
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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 |
- Best Corrected Binocular Visual Acuity [ Time Frame: 1 week ]Early Treatment of Diabetic Retinopathy Study Vision Testing Protocol of Best corrected Binocular Acuity
- Visual Function [ Time Frame: 5 Days ]THe Validated Amblyopia and Visual Function Questionnaire will be administered

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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

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 ClinicalTrials.gov identifier (NCT number): NCT01312402
United States, Ohio | |
Akron Children's Hospital | |
Akron, Ohio, United States, 44308 |
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Richard W. Hertle, MD, Akron Children's Hospital |
ClinicalTrials.gov 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 |
Nystagmus, Pathologic Syndrome 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 |