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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.
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:
Safety will be evaluated by:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Brinzolamide (Azopt) | Active Comparator | ophthalmic drop given three times a day |
|
| placebo ophthalmic drop in 5 mL solution | Placebo Comparator | masked non-active eye drop (absence of Brinzolamide) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| topical brinzolamide 1% in 5mL ophthalmic medication | Drug | 1 drop three times a day in both eyes on days 2,3 and 4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Binocular Visual Acuity | Early Treatment of Diabetic Retinopathy Study Vision Testing Protocol of Best corrected Binocular Acuity | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Function | THe Validated Amblyopia and Visual Function Questionnaire will be administered | 5 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard W. Hertle, M.D. | Akron Children's Hospital | Principal Investigator |
| Dongsheng Yang, Ph.D. | Akron Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akron Children's Hospital | Akron | Ohio | 44308 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12076015 | Background | 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. | |
| 14597515 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 24, 2016 | |
| Reset | Aug 2, 2016 | |
| Release | Jan 23, 2017 |
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| Placebo in 5 mL dispenser | Drug | Placebo ophthalmic solution in 5 mL dispenser; 1 drop three times a day on days 2,3 and 4 |
|
| 15629289 | Background | 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. |
| 15616501 | Background | 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. |
| 16799026 | Background | 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. |
| 19458334 | Background | 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. |
| 25336575 | Derived | 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. |
| Reset | Mar 13, 2017 |
| Release | Jun 25, 2018 |
| Reset | Jul 20, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 24, 2016 | Aug 2, 2016 | |||
| Jan 23, 2017 | Mar 13, 2017 | |||
| Jun 25, 2018 | Jul 20, 2018 |
| ID | Term |
|---|---|
| C111827 | brinzolamide |
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