- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00944710
Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old (ATS16)
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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California
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Fullerton, California, United States, 92831
- Southern California College of Optometry
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Eye Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Major Eligibility Criteria for Run-in Phase
- Age 3 to < 8 years
- Amblyopia associated with strabismus, anisometropia, or both
- Visual acuity in the amblyopic eye between 20/50 and 20/400 inclusive
- Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference >3 logMAR lines
Amblyopia treatment within the past 6 months subject to the following stipulations:
- No more than 6 weeks of any amblyopia treatment other than spectacles (except for patients being treated with atropine who are entering the study on treatment)
- No simultaneous treatment with patching and atropine
- No use of atropine in combination with the sound eye spectacle lens reduced by more than 1.50 D
Maximum level of treatment within the past 6 months:
- Patching: up to 2 hours daily
- Atropine: up to once daily
- Wearing spectacles with optimal correction (if amblyopic eye acuity is 20/80 or better, then VA must be stable in glasses; if amblyopic eye acuity is 20/100 or worse, then spectacles and atropine can be initiated simultaneously).
- Hypermetropia and spectacle correction in sound eye of +1.50 D or more
Eligibility Criteria for Randomization:
- Amblyopic eye acuity of 20/40 to 20/160 with an inter-ocular difference of >2 lines, or amblyopic eye acuity of 20/32 with 3 lines of IOD.
- Compliance with weekend atropine treatment based on investigator judgment.
Exclusion Criteria:
- Currently using vision therapy or orthoptics
- Ocular cause for reduced visual acuity (nystagmus per se does not exclude the patient if the above visual acuity criteria are met)
- Prior intraocular or refractive surgery
- Known allergy to atropine or other cycloplegic drugs
- Down Syndrome present
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intensified treatment
Weekend atropine 1% with plano lens over the sound eye
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Weekend atropine 1%
plano lens over the sound eye
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Active Comparator: Control
Weekend atropine 1%
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Weekend atropine 1%
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distribution of 10-week Amblyopic-Eye Visual Acuity
Time Frame: 10 weeks after randomization
|
The masked 10-week amblyopic eye visual acuity scores were tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis. |
10 weeks after randomization
|
Mean 10-week Amblyopic-Eye Visual Acuity
Time Frame: 10 weeks after randomization
|
The primary outcome analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis. |
10 weeks after randomization
|
Distribution of the Change in Amblyopic-Eye Visual Acuity
Time Frame: Randomization to 10 weeks
|
The change in 10-week amblyopic eye visual acuity scores since randomization was tabulated for both treatment groups, and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis. |
Randomization to 10 weeks
|
Mean Change in Amblyopic-Eye Visual Acuity at 10 Weeks From Randomization
Time Frame: Randomization to 10 weeks
|
The change in 10-week amblyopic eye visual acuity was computed for both treatment groups and included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) with no imputation for missing data. The primary outcome analysis followed the "intent-to-treat" principle. Therefore, data from randomized participants were included in the analysis regardless of whether the assigned treatment was actually received or whether they deviated from treatment against protocol. In addition, randomized participants who were found to be ineligible upon subsequent review of enrollment data were included in the primary outcome analysis. |
Randomization to 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines at 10 Weeks Since Randomization
Time Frame: 10 weeks after randomization
|
The proportion of participants who improved at least 2 logMAR lines since randomization was computed at the 10-week outcome. The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity improved at least 2 logMAR lines since randomization using logistic regression, adjusting for visual acuity at randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis. |
10 weeks after randomization
|
Mean Amblyopic Eye Visual at Randomization According to Baseline Characteristics for 10-week Outcome
Time Frame: 10 weeks after randomization
|
Mean amblyopic eye visual acuity at randomization was computed by treatment group within categorical levels of prespecified baseline subgroup factors.
The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
|
10 weeks after randomization
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Treatment Comparison of Mean Amblyopic Eye Visual Acuity Change at 10-weeks According to Baseline Characteristics
Time Frame: 10 weeks after randomization
|
A treatment comparison of mean amblyopic eye visual acuity change since randomization was performed at the 10-week outcome according to categorical levels of prespecified baseline subgroup factors.
The analysis included data from participants with 10-week exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis.
|
10 weeks after randomization
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Treatment Group Comparison of the Proportion of Participants Who Achieved 20/25 or Better Visual Acuity at 10 Weeks Since Randomization
Time Frame: 10 weeks after randomization
|
The proportion of participants who achieved 20/25 or better visual acuity since randomization was computed at the 10-week outcome. The secondary outcome analysis was a treatment group comparison of the proportion of participants whose 10-week masked amblyopic eye visual acuity was 20/25 or better since randomization. The analysis included data from 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to the principles specified in the primary outcome analysis. |
10 weeks after randomization
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Spectacle Compliance at 10 Weeks by Treatment Group
Time Frame: 10 weeks after randomization
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The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome.
Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.
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10 weeks after randomization
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Average Spectacle Compliance by Treatment Group
Time Frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
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The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits.
Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.
|
10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
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Atropine Compliance at 10 Weeks by Treatment Group
Time Frame: 10 weeks after randomization
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The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome.
Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.
|
10 weeks after randomization
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Average Atropine Compliance by Treatment Group
Time Frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
|
The distribution of compliance with prescribed treatment was tabulated for the 10-week outcome and as averaged scores across all study follow-up visits.
Compliance was evaluated as excellent (>75%), good (51%-75%), fair (26%-50%), or poor (<26%) based on discussions with the parent and by reviewing study calendars maintained by the parent, who recorded the frequency of atropine administration.
|
10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
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Distribution of Interocular Difference at 12-week Exam
Time Frame: 12 weeks after randomization
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Distribution of Interocular Difference Between Eyes at 12-week Exam
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12 weeks after randomization
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Mean Interocular Difference at 12-week Exam
Time Frame: 12 weeks after randomization
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Mean Interocular Difference Between Eyes at 12-week Exam
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12 weeks after randomization
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Distribution of 12-week Fellow-Eye Visual Acuity
Time Frame: 12 weeks after randomization
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Following the 10-week primary outcome exam, participants discontinued the randomized treatment and returned 2 weeks later for a 12-week visit to measure off-treatment fellow-eye visual acuity.
|
12 weeks after randomization
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Mean Fellow-Eye Visual Acuity at 12-week Exam
Time Frame: 12 weeks after randomization
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12 weeks after randomization
|
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Distribution of Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization
Time Frame: 12 weeks after randomization
|
12 weeks after randomization
|
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Mean Change in Fellow-Eye Visual Acuity at 12 Weeks From Randomization
Time Frame: 12 weeks after randomization
|
12 weeks after randomization
|
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Distribution of Baseline Characteristics at the 10-week Outcome
Time Frame: 10 weeks after randomization
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The number of participants was tabulated by treatment group within categorical levels of prespecified baseline subgroup factors for participants with 10-week visual acuity exams completed between 8 to 15 weeks (inclusive) according to principles specified in the primary outcome analysis.
|
10 weeks after randomization
|
Distribution of Amblyopic-Eye Visual Acuity at Best Outcome Visit
Time Frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
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Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit.
The distribution of best post-randomization (10 weeks or later) visual acuity scores in the amblyopic eye was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)
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10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
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Mean Amblyopic-Eye Visual Acuity at Best Outcome Visit
Time Frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
|
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit.
A treatment comparison of mean amblyopic eye visual acuity at the visit of best post-randomization visual acuity (10 weeks or later) was performed using an analysis of covariance, adjusting for amblyopic eye visual acuity at randomization.
|
10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
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Distribution of Change in Amblyopic-Eye Visual Acuity From Randomization to Best Outcome Visit
Time Frame: Randomization to 10 weeks or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
|
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit.
The distribution of change in best post-randomization (10 weeks or later) visual acuity in the amblyopic eye since randomization was tabulated for both treatment groups using the initial visual acuity score (if a retest was obtained.)
|
Randomization to 10 weeks or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
|
Mean Change in Amblyopic-Eye Visual Acuity at Best Outcome Visit
Time Frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
|
Participants in both groups who have improved by one or more lines from randomization to the 10-week outcome exam will continue in the study and visits will occur every 10 weeks until no improvement of one or more lines from the previous visit.
The mean change in amblyopic eye visual acuity since randomization was computed for both treatment groups based on the visit of best post-randomization visual acuity (10 weeks or later) using the initial visual acuity score (if a retest was obtained.)
|
10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
|
Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines Based on Visual Acuity at Best Outcome Visit
Time Frame: 10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
|
10 weeks after randomization or later (until no further VA improvement, up to maximum of 84 weeks for one subject)
|
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Distribution of Randot Preschool Stereoacuity Score at 12 Weeks
Time Frame: 12 weeks after randomization
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Distribution of Randot Preschool Stereoacuity Score at 12 Weeks; Participants with a Randot Preschool test of >800 seconds of arc were classified as having a stereoacuity of 3000 seconds of arc if the Titmus fly test was positive or as nil if the Titmus fly test was negative.
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12 weeks after randomization
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Distribution of Randot Preschool Stereoacuity Scores at 12 Weeks for Participants With Anisometropic Amblyopia
Time Frame: 12 weeks after randomization
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12 weeks after randomization
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Eye Diseases
- Neurologic Manifestations
- Sensation Disorders
- Vision Disorders
- Amblyopia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Adjuvants, Anesthesia
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Mydriatics
- Atropine
Other Study ID Numbers
- NEI-144
- 2U10EY011751 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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