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NCT01312402 · ClinicalTrials.gov registry record · Phase 4
Topical Brinzolamide Ophthalmic Suspension Versus Placebo in the Treatment of Infantile Nystagmus Syndrome
A Phase 4 study, sponsored by Akron Children's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT01312402 is a Phase 4 study that has completed, run by Akron Children's Hospital. The registered enrollment target is 5 participants.
The verdict
NCT01312402, a Phase 4 study, has completed, sponsored by Akron Children's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study 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.
Interventions
- DRUG topical brinzolamide 1% in 5mL ophthalmic medication
- DRUG Placebo in 5 mL dispenser
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2011-01 |
| Est. Completion | 2014-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01312402
The ClinicalTrials.gov registry entry for NCT01312402 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Akron Children's Hospital, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which topical brinzolamide 1% in 5mL ophthalmic medication is the first listed.
NCT01312402 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01312402 about?
NCT01312402 is a clinical study titled "Topical Brinzolamide Ophthalmic Suspension Versus Placebo in the Treatment of Infantile Nystagmus Syndrome". 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 cl...
What is the current status of trial NCT01312402?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2011-01. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01312402?
The interventions under investigation include: topical brinzolamide 1% in 5mL ophthalmic medication (DRUG), Placebo in 5 mL dispenser (DRUG).
Who is sponsoring clinical trial NCT01312402?
This trial is sponsored by Akron Children's Hospital, which has 27 total clinical trials registered on ClinicalTrials.gov.
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