Table 4.
Secondary outcomes were evaluated at 1, 3 and 6 months
| Outcome measure | Treatment | Baseline | 1 Month | 3 Month | 6 Month | N | p-values */**/*** |
|---|---|---|---|---|---|---|---|
| TBUT | T | 3±3 | 3±3 | 3±3 | 3±3 | 24 | <0.9/0.5/0.3 |
| S | 3±2 | 3±3 | 3±3 | 2±2 | 25 | ||
| Schirmer’s test | T | 10±8 | 9±6 | 10±7 | 11±9 | 24 | <0.3/0.4/0.3 |
| S | 9±7 | 11±7 | 8±4 | 10±6 | 25 | ||
| Ocular surface grading | T | 8±4 | 6±4 | 7±4 | 7±4 | 24 | <0.5/0.1/0.4 |
| S | 6±3 | 5±3 | 6±3 | 6±2 | 25 | ||
| Artificial tear application (questionnaire) | T | 3±3 | 3±3 | 3±3 | 2±2 | 24 | <0.5/0.3/0.3 |
| S | 4±3 | 3±3 | 3±2 | 3±3 | 25 | ||
| Frequency of eye closing (questionnaire) | T | 6±4 | 3±4 | 3±5 | 3±4 | 24 | <0.2/0.002/0.2 |
| S | 5±4 | 3±3 | 4±4 | 3±3 | 25 |
Notes: *Comparison of True vs Sham treatment groups. **Compared to baseline within the True treatment group. ***Compared to baseline within the Sham treatment group. Data are presented as mean ± SD.
Abbreviations: T, true treatment; S, sham treatment; TBUT, tear film break-up time.