Trial · NCT01190813
Registered outcomes43
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 43
Download this page as JSON| 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. |
| Secondary | Amblyopia Resolution at 10 Weeks | 10 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. |
| Secondary | Amblyopia Resolution at 16 Weeks | 16 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. |
| Secondary | Amblyopia Resolution at 18 Weeks | 18 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. |
| Secondary | Amblyopia Resolution at 26 Weeks | 26 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. |
| Secondary | Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 4 Weeks | 4 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 | Mean Change in Amblyopic Eye Visual Acuity From Baseline at 4 Weeks | 4 weeks after enrollment | A treatment group comparison of the mean amblyopic eye visual acuity at 4 weeks after enrollment, adjusted for baseline acuity. |
| Secondary | Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 10 Weeks | 10 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 | Mean Change in Amblyopic Eye Visual Acuity From Baseline at 10 Weeks | 10 weeks after enrollment | A treatment group comparison of the mean amblyopic eye visual acuity at 10 weeks after enrollment, 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 | Distribution of Amblyopic Eye Visual Acuity Change From Baseline at 16 Weeks | 16 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 | Mean Change in Amblyopic Eye Visual Acuity From Baseline at 16 Weeks | 16 weeks after enrollment | A treatment group comparison of the mean amblyopic eye visual acuity at 16 weeks after enrollment, 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT01190813/registered