Trial · NCT01190813

Levodopa for the Treatment of Residual Amblyopia

NCT01190813, Phase 3, Completed, Jaeb Center for Health Research; results first posted 2015-02-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Levodopa for the Treatment of Residual Amblyopia. Trials, record NCT01190813. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01190813

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Levodopa for the Treatment of Residual Amblyopia
NCT number: NCT01190813
Status: Completed
Phases: Phase 3
Enrollment: 139 participants, actual
Lead sponsor: Jaeb Center for Health Research
Conditions: Amblyopia
Interventions: Levodopa/Carbidopa, Placebo, Patching
First posted: 2010-08-30
Last updated: 2016-06-02
Results first posted: 2015-02-13

Source ClinicalTrials.gov

Registered outcomes43

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Distribution of Amblyopic Eye Visual Acuity Change From Baseline	18 weeks after enrollment	The primary outcome is the amblyopic eye visual acuity letter score measured at the 18-week primary outcome visit following a rapid taper of study medicine beginning at week 16. The primary analytic approach will be a treatment group comparison of the mean amblyopic eye visual acuity adjusted for baseline acuity. Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.
Primary	Mean Amblyopic Eye Visual Acuity Change From Baseline	18 weeks after enrollment	The primary outcome is the amblyopic eye visual acuity letter score measured at the 18-week primary outcome visit following a rapid taper of study medicine beginning at week 16. The primary analytic approach will be a treatment group comparison of the mean amblyopic eye visual acuity adjusted for baseline acuity. Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.
Secondary	Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 18 Weeks	18 weeks after enrollment	Treatment group comparisons of the proportion of subjects who have improved from baseline by 10 or more letters.
Secondary	Distribution of Amblyopic Eye Visual Acuity at 18 Weeks	18 weeks after enrollment
Secondary	Mean Amblyopic Eye Visual Acuity at 18 Weeks	18 weeks after enrollment	Visual acuity was measured in each eye (right eye first) by a study-certified VA tester using the Electronic Early Treatment of Diabetic Retinopathy Study (E-ETDRS©) visual acuity protocol. Five letters is equivalent to one logMAR line.
Secondary	Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 4 Weeks	4 weeks after enrollment	Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects who have improved from baseline by 10 or more letters.
Secondary	Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 10 Weeks	10 weeks after enrollment	Treatment group comparisons of the proportion of subjects who have improved from baseline by 10 or more letters.
Secondary	Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 16 Weeks	16 weeks after enrollment	Treatment group comparisons of the proportion of subjects who have improved from baseline by 10 or more letters.
Secondary	Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 26 Weeks	26 weeks after enrollment	Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects who have improved from baseline by 10 or more letters.
Secondary	Amblyopia Resolutionat 4 Weeks	4 weeks after enrollment	Treatment group comparisons adjusted for baseline acuity scores using logistic regression of the proportion of subjects with 20/25 or better visual acuity.

1 to 10 of 43Source ClinicalTrials.gov

See all 43 registered outcomes

Outcomes43

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Distribution of Amblyopic Eye Visual Acuity Change From Baseline	18 weeks after enrollment	The ITT principle was followed. For subjects with no visit in the +/- 1 wk window for the 18-wk visit, data from a visit 14-27 wks after randomization were used, if available. Multiple imputation by the Monte Carlo Markov Chain method was used for missing 18-wk VA outcomes based on tx group, baseline VA, \& VA scores from completed follow-up visits.	participants	NUMBER
SECONDARY	Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 18 Weeks	18 weeks after enrollment	The analysis followed the intent-to-treat principle. For missing primary outcome visits (±1 wk), data from a visit 14-27 wks after randomization were used, if available.Multiple imputation(Monte Carlo Markov Chain method) was used for missing 18-wk VA outcomes based on treatment group, baseline VA, and VA scores from completed follow-up visits	participants	NUMBER
SECONDARY	Distribution of Amblyopic Eye Visual Acuity at 18 Weeks	18 weeks after enrollment		participants	NUMBER
SECONDARY	Mean Amblyopic Eye Visual Acuity at 18 Weeks	18 weeks after enrollment		letters	MEAN
SECONDARY	Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 4 Weeks	4 weeks after enrollment		participants	NUMBER
SECONDARY	Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 10 Weeks	10 weeks after enrollment		participants	NUMBER
SECONDARY	Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 16 Weeks	16 weeks after enrollment		participants	NUMBER
SECONDARY	Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 26 Weeks	26 weeks after enrollment		participants	NUMBER
SECONDARY	Amblyopia Resolutionat 4 Weeks	4 weeks after enrollment		participants	NUMBER
SECONDARY	Amblyopia Resolution at 10 Weeks	10 weeks after enrollment		participants	NUMBER

1 to 10 of 43Source ClinicalTrials.gov

See all 43 outcomes

Results by group204

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Distribution of Amblyopic Eye Visual Acuity Change From Baseline	Levodopa/Carbidopa	10-14 letters worse	0	participants
Distribution of Amblyopic Eye Visual Acuity Change From Baseline	Placebo	10-14 letters worse	0	participants
Distribution of Amblyopic Eye Visual Acuity Change From Baseline	Levodopa/Carbidopa	5-9 letters worse	2	participants
Distribution of Amblyopic Eye Visual Acuity Change From Baseline	Placebo	5-9 letters worse	1	participants
Distribution of Amblyopic Eye Visual Acuity Change From Baseline	Levodopa/Carbidopa	within 4 letters	35	participants
Distribution of Amblyopic Eye Visual Acuity Change From Baseline	Placebo	within 4 letters	23	participants
Distribution of Amblyopic Eye Visual Acuity Change From Baseline	Levodopa/Carbidopa	5-9 letters better	36	participants
Distribution of Amblyopic Eye Visual Acuity Change From Baseline	Placebo	5-9 letters better	19	participants
Distribution of Amblyopic Eye Visual Acuity Change From Baseline	Levodopa/Carbidopa	10-14 letters better	10	participants
Distribution of Amblyopic Eye Visual Acuity Change From Baseline	Placebo	10-14 letters better	1	participants

1 to 10 of 204Source ClinicalTrials.gov

See all 204 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Levodopa/Carbidopa	90
Overall Study	STARTED	Placebo	49
Overall Study	2-week Phone Call	Levodopa/Carbidopa	87
Overall Study	2-week Phone Call	Placebo	48
Overall Study	4-week Visit	Levodopa/Carbidopa	88
Overall Study	4-week Visit	Placebo	47
Overall Study	7-week Phone Call	Levodopa/Carbidopa	85
Overall Study	7-week Phone Call	Placebo	46
Overall Study	10-week Visit	Levodopa/Carbidopa	88
Overall Study	10-week Visit	Placebo	48

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	General disorders	Levodopa/Carbidopa	18	90	23
other	Headache	General disorders	Placebo	4	49	6
other	Nausea	General disorders	Levodopa/Carbidopa	6	90	7
other	Nausea	General disorders	Placebo	6	49	6
other	Cough	General disorders	Levodopa/Carbidopa	4	90	4
other	Cough	General disorders	Placebo	3	49	4
other	Gastroenteritis viral	Gastrointestinal disorders	Levodopa/Carbidopa	4	90	5
other	Gastroenteritis viral	Gastrointestinal disorders	Placebo	3	49	3
other	Nasopharyngitis	General disorders	Levodopa/Carbidopa	4	90	4
other	Nasopharyngitis	General disorders	Placebo	4	49	4

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Levodopa/Carbidopa
Total, all-cause mortality	Placebo
Total, other adverse events	Levodopa/Carbidopa	37	90
Total, other adverse events	Placebo	17	49
Total, serious adverse events	Levodopa/Carbidopa	0	90
Total, serious adverse events	Placebo	0	49

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25676904	RESULT

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10EY011751	Pediatric Eye Disease Investigator Group Coordinating Center	KRAKER, RAYMOND	JAEB CENTER FOR HEALTH RESEARCH, INC.	NATIONAL EYE INSTITUTE	1997 to 2018

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Levodopa/Carbidopa vs Placebo: Amblyopic Eye Visual Acuity Improvement Treatment Group Comparison at 18 Weeks	Trial comparisons
Levodopa/Carbidopa vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01190813

GET https://conductscience.org/api/trials/v1/NCT01190813/registered?page=2

API reference For AI assistants