Table 3.
Results of Primary and Secondary Endpoints for Evaporative (EDE) and Non-Evaporative Dry Eye (NEDE) Groups
EDE Group (N=54) | NEDE Group (N=18) | |||||||
---|---|---|---|---|---|---|---|---|
Endpoints | Total | Mean±SD | P§ | Total | Mean±SD | P§ | ||
VSE | CTN | VSE | CTN | |||||
TBUT (sec) | ||||||||
Baseline | 3.3±1.6 | 3.3±1.6 | 2.9±1.1 | 2.9±1.2 | ||||
Intermediate visit | 4.6±1.8 | 4.6±1.8** | 4.6±1.8** | 0.08 | 4.1±2.4 | 4.1±2.4* | 4.1±2.4* | 0.29 |
Final visit | 6.0±2.8 | 5.6±2.4** | 6.5±2.8** | 0.74 | 4.6±2.4 | 4.6±2.3* | 4.6±2.6* | 0.30 |
OSDI questionnaire score | ||||||||
Baseline | 39±13 | 39±13 | 32±8 | 32±8 | ||||
Intermediate visit | 24±15 | 24±15** | 24±15** | 0.44 | 20±15 | 20±15* | 20±15* | 0.46 |
Final visit | 20±13 | 20±15** | 20±15** | 0.38 | 18±12 | 18±11** | 18±14* | 0.49 |
Schirmer I test (mm/5 min) | ||||||||
Baseline | 16±5 | 16±5 | 16±6 | 16±6 | ||||
Intermediate visit | 16±8 | 16±8 | 16±8 | 0.38 | 14±9 | 14±9 | 14±9 | 0.44 |
Final visit | 14±9 | 15±9 | 14±9 | 0.34 | 16±10 | 17±11 | 16±10 | 0.40 |
Complete blinkings (N/min) | ||||||||
Baseline | 16±13 | 16±13 | 9±5 | 9±5 | ||||
Intermediate visit | 19±10 | 19±10 | 19±10 | 0.43 | 11±8 | 11±8 | 11±8 | 0.46 |
Final visit | 22±18 | 20±15 | 25±21 | 0.81 | 8±5 | 7±4 | 9±6 | 0.77 |
Incomplete blinkings (N/min) | ||||||||
Baseline | 7±6 | 7±6 | 11±9 | 11±9 | ||||
Intermediate visit | 5±5 | 5±5 | 5±5 | 0.37 | 3±3 | 3±3* | 3±3* | 0.40 |
Final visit | 3±4 | 4±5 | 2±2** | 0.005 | 3±4** | 5±4* | 1±2 | 0.04 |
Total blinkings (N/min) | ||||||||
Baseline | 23±12 | 23±12 | 20±13 | 20±13 | ||||
Intermediate visit | 24±13 | 24±13 | 24±13 | 0.45 | 13±7 | 13±7 | 13±7 | 0.45 |
Final visit | 25±17 | 24±15 | 27±20 | 0.68 | 11±6** | 13±6* | 10±6** | 0.22 |
Osmolarity (mOsm/L) | ||||||||
Baseline | 313±20 | 313±20 | 318±30 | 318±30 | ||||
Intermediate visit | 309±15 | 309±15 | 309±15 | 0.47 | 296±17 | 296±17 | 296±17 | 0.48 |
Final visit | 305±15 | 307±14 | 303±17 | 0.26 | 308±23 | 299±18 | 318±26 | 0.85 |
Notes: §Paired T-test to compare two treatment group, adjusting by baseline value. *T-test vs baseline, p<0.05. **T-test vs baseline, p<0.001.
Abbreviations: CTN, Cationorm; VSE, VisuEvo.