Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study, sponsored by Akron Children's Hospital.
NCT01312402 is a Phase 4 study that has completed, run by Akron Children's Hospital. The registered enrollment target is 5 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Early Treatment of Diabetic Retinopathy Study Vision Testing Protocol of Best corrected Binocular Acuity
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 |
What the finished NCT01312402 record still lists
NCT01312402 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which topical brinzolamide 1% in 5mL ophthalmic medication is the first listed.
NCT01312402 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01312402's enrollment target sits among peer trials
5 1989th of 2000 higher than 7 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia