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NCT00944710 · ClinicalTrials.gov registry record · Phase 3

Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old

A Phase 3 study of Amblyopia, sponsored by Jaeb Center for Health Research.

Completed
Registry status
Phase 3
Development phase
73
Enrollment target
2
Study locations

NCT00944710 is a Phase 3 study of Amblyopia that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 73 participants, below the 163-participant average among 24 other Amblyopia trials with a reported enrollment target (55% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT00944710, a Phase 3 study of Amblyopia, has completed, sponsored by Jaeb Center for Health Research.

COMPLETED
Registry status
Phase 3
Development phase
73 participants
Enrollment target
2
Study locations

Study Summary

This study is designed to evaluate the effectiveness of adding a plano lens to weekend atropine after visual acuity has stabilized with weekend atropine but amblyopia is still present. Children ages 3 to \<8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-in phase with weekend atropine until no improvement, followed by randomization of eligible patients to weekend atropine treatment with a plano lens over the sound eye versus without a plano lens over the sound eye. The primary objective is to determine if adding a plano lens to weekend atropine will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.

Conditions Studied

Amblyopia

Interventions

  • DRUG Atropine
  • DEVICE Plano lens

Study Locations (2)

California

  • Southern California College of Optometry - Fullerton

North Carolina

  • Duke University Eye Center - Durham

Trial Details

FieldValue
Enrollment Target 73 participants
Start Date 2009-08
Est. Completion 2013-11
Phase Phase 3

Sponsor

Jaeb Center for Health Research

119 total trials

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What the Registry Record Tells You About NCT00944710

The ClinicalTrials.gov registry entry for NCT00944710 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 163-participant average among 24 other Amblyopia trials with a reported enrollment target (55% lower). The listed sponsor is Jaeb Center for Health Research, which has 119 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Amblyopia appearing as the primary indexed condition, and to 2 interventions - of which Atropine is the first listed.

NCT00944710 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, North Carolina.

Frequently Asked Questions

What is clinical trial NCT00944710 about?

NCT00944710 is a clinical study titled "Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old". This study is designed to evaluate the effectiveness of adding a plano lens to weekend atropine after visual acuity has stabilized with weekend atropine but amblyopia is still present. Children ages 3 to \<8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-i...

What is the current status of trial NCT00944710?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 73 participants. The study started on 2009-08. Estimated completion is 2013-11.

What conditions does trial NCT00944710 study?

This clinical trial studies the following conditions: Amblyopia.

What interventions are being tested in trial NCT00944710?

The interventions under investigation include: Atropine (DRUG), Plano lens (DEVICE).

Who is sponsoring clinical trial NCT00944710?

This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00944710 being conducted?

This trial has 2 study locations across California, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.