Topical Brinzolamide Ophthalmic Suspension Versus Placebo in the Treatment of Infantile Nystagmus… (NCT01312402) | Clinical Trial Compass
CompletedPhase 4
Topical Brinzolamide Ophthalmic Suspension Versus Placebo in the Treatment of Infantile Nystagmus Syndrome
United States5 participantsStarted 2011-01
Plain-language 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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.