Table 1.
Demographic data and clinical assessments at day 1
| Intent-to-treat population N=37 | |
|---|---|
| Age, years | |
| N | 37 |
| Mean ± SD | 59.6±19.0 |
| Median | 66.0 |
| (Min, max) | (18, 82) |
| Age, years | |
| N | 37 |
| 18–64 | 17 (45.9%) |
| 65–84 | 20 (54.1%) |
| Gender | |
| N | 37 |
| Male | 11 (29.7%) |
| Female | 26 (70.3%) |
| Diagnosis | |
| N | 37 |
| DED caused by hypersecretion related or not to a Sjögren’s syndrome | 8 (21.6%) |
| DED caused by excessive evaporation | 29 (78.4%) |
| Duration, years | |
| N | 36 |
| Mean ± SD | 6.60±5.42 |
| Median | 5.10 |
| (Min, max) | (0.0, 21.9) |
| Oxford grade | |
| N | 74 |
| I | 1 (1.4%) |
| II | 57 (77.0%) |
| III | 16 (21.6%) |
| Mean ± SD | 2.20±0.44 |
| Median | 2.00 |
| (Min, max) | (1, 3) |
| Tear break-up time, seconds | |
| N | 74 |
| Mean ± SD | 5.841±0.861 |
| Median | 5.70 |
| (Min, max) | (4.3, 8.3) |
| Schirmer, mm/5 minutes | |
| N | 74 |
| Mean ± SD | 8.30±1.41 |
| Median | 8.00 |
| (Min, max) | (5, 12) |
| Intraocular pressure, mmHg | |
| N | 74 |
| Mean ± SD | 13.59±3.36 |
| Median | 14.00 |
| (Min, max) | (6, 20) |
| Naso-bulbar conjunctival lesion, score | |
| N | 70 |
| Mean ± SD | 1.36±0.50 |
| Median | 1.00 |
| (Min, max) | (1, 3) |
| Temporal-bulbar conjunctival lesion, score | |
| N | 74 |
| Mean ± SD | 1.35±0.53 |
| Median | 1.00 |
| (Min, max) | (1, 3) |
| Cornea, score | |
| N | 74 |
| Mean ± SD | 1.44±0.49 |
| Median | 1.00 |
| (Min, max) | (1, 2) |
| Visual acuity | |
| N | 74 |
| Mean ± SD | 8.7076±2.0437 |
| Median | 10.00 |
| (Min, max) | (0.06, 10.00) |
Abbreviation: DED, dry eye disease.