Table 3.
Amblyopic-Eye Visual Acuity by Treatment Group
| Amblyopic Eye | 4-week Visit | 10-week Visit | 16-week Visit | 18-week Primary Outcome Visit |
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Levodopa N=88 |
Placebo N=47 |
Levodopa N=88 |
Placebo N=48 |
Levodopa N=87 |
Placebo N=46 |
Levodopa N=86* |
Placebo N=45 |
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| N | % | N | % | N | % | N | % | N | % | N | % | N | % | N | % | |
| Change from Baseline | ||||||||||||||||
| 10–14 letters worse | 0 | 0 | 0 | 0 | 1 | 1% | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 5–9 letters worse | 6 | 7% | 2 | 4% | 4 | 5% | 1 | 2% | 1 | 1% | 0 | 0 | 2 | 2% | 1 | 2% |
| within 4 letters (±4) | 55 | 63% | 28 | 60% | 43 | 49% | 30 | 63% | 41 | 47% | 26 | 57% | 35 | 41% | 23 | 51% |
| 5–9 letters better | 23 | 26% | 15 | 32% | 30 | 34% | 8 | 17% | 30 | 34% | 10 | 22% | 36 | 42% | 19 | 42% |
| 10–14 letters better | 4 | 5% | 1 | 2% | 7 | 8% | 9 | 19% | 9 | 10% | 10 | 22% | 10 | 12% | 1 | 2% |
| ≥15 letters better | 0 | 0 | 1 | 2% | 3 | 3% | 0 | 0 | 6 | 7% | 0 | 0 | 3 | 3% | 1 | 2% |
| Mean (SD) letter change | 2.2 (4.1) | 2.5 (4.7) | 3.8 (4.9) | 3.7 (4.9) | 5.1 (6.3) | 4.2 (4.9) | 5.2 (5.3) | 3.8 (5.0) | ||||||||
|
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| Difference (Levodopa – Placebo) between treatment groups† | −0.3 letter | +0.1 letter | +0.9 letter | +1.4 letters | ||||||||||||
|
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| 1-sided P-value | 0.65 | 0.44 | 0.20 | 0.06 | ||||||||||||
|
| ||||||||||||||||
| 2-sided 95% CI for difference (letters) | (−1.9 to +1.3) | (−1.6 to +1.8) | (−1.2 to +2.9) | (−0.4 to +3.3) | ||||||||||||
|
| ||||||||||||||||
| Proportion 10 or more letters improved | 4 (5%) | 2(4%) | 10 (11%) | 9 (19%) | 15 (17%) | 10 (22%) | 13 (15%) | 2 (4%) | ||||||||
|
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| Treatment group difference (Levodopa – Placebo) | 0% | −7% | −5% | +11% | ||||||||||||
|
| ||||||||||||||||
| 2-sided 95% CI for difference | (−17% to +18%) | (−25% to +10%) | (−22% to +13%) | (−7% to + 28%) | ||||||||||||
SD = standard deviation; CI = confidence interval
*
Note: one participant completing the 18-week visit 288 days (41 weeks) post randomization is not included in the analysis as pre-specified in the analysis plan.
†
Positive values favor the levodopa group and negative values favor the placebo group. The treatment comparison was performed using analysis of covariance adjusting for amblyopic-eye visual acuity at randomization with multiple imputation for missing visual acuity.