Inclusion characteristics of the “per protocol” set of patients evaluated for the efficacy analysis. Values for each patient were assessed before randomisation and are expressed as mean (SD) of the right and left eye
| Demographic variable | Sodium hyaluronate group | Placebo (saline) group |
|---|---|---|
| Symptom scores were calculated according to McMonnies and Ho.12 | ||
| AU= arbitrary units.13 | ||
| Number of patients | 19 | 25 |
| Age | 50.2 (15.1) | 50.7 (15) |
| Sex (M/F) | 4/15 | 5/20 |
| Symptom score | 16.2 (2.4) | 16.8 (2.7) |
| Anesthetised Schirmer's test (mm) | 7.1 (4.8) | 6.0 (3.8) |
| Break up time (seconds) | 6.4 (2.6) | 5.1 (2.3) |
| Rose bengal stain (AU) | 4.0 (2.4) | 6.0 (2.9) |
| Fluorescein stain (AU) | 3.2 (2.1) | 3.6 (3.3) |