Table 2.
Demographics and Baseline Characteristics for the Full Analysis Set
| CyclASol 0.05% (n = 51) | CyclASol 0.1% (n = 51) | Vehicle (n = 52) | Restasis (n = 53) | |
|---|---|---|---|---|
| Sex, n (%) | ||||
| Male | 13 (25.5%) | 15 (29.4%) | 13 (25.0%) | 13 (24.5%) |
| Female | 38 (74.5%) | 36 (70.6%) | 39 (75.0%) | 40 (75.5%) |
| Age | ||||
| Mean (years) | 64.3±10.72 | 61.1±12.29 | 61.3±10.45 | 62.8±11.90 |
| <65 years, n (%) | 26 (51.0%) | 32 (62.7%) | 31 (59.6%) | 35 (66.0%) |
| ≥65 years, n (%) | 25 (49.0%) | 19 (37.3%) | 21 (40.4%) | 18 (34.0%) |
| Total CFS (NEI scale) | 8.78±2.138 | 8.75±1.885 | 8.71±2.145 | 8.83±1.889 |
| Central CFS (NEI scale) | 1.49±0.612 | 1.37±0.631 | 1.40±0.721 | 1.36±0.653 |
| Total conjunctival staining (Oxford scale) | 4.12±1.381 | 3.94±1.348 | 4.04±1.220 | 4.70±1.624 |
| Unanesthetized Schirmer test I | 5.10±2.128 | 5.16±2.158 | 4.63±2.327 | 4.42±1.896 |
| MMP9, n (%) | ||||
| Positive | 27 (52.9%) | 18 (35.3%) | 26 (50.0%) | 32 (60.4%) |
| Negative | 24 (47.1%) | 33 (64.7%) | 26 (50.0%) | 21 (39.6%) |
| Severity of dryness VAS | 64.18±15.058 | 64.51±14.251 | 64.63±15.449 | 63.94±15.318 |
| Total OSDI score | 38.02±18.653 | 40.37±19.317 | 37.91±16.477 | 35.38±16.641 |
CFS = corneal fluorescein staining; MMP9 = Matrix Metallopeptidase 9; NEI = National Eye Institute; OSDI = Ocular Surface Disease Index; VAS = visual analog scale.