Table 1

Mean (±1 SD) values for all efficacy and safety parameters for test and control eyes at baseline and follow-up

 BaselineFollow-upTest eye compared to baseline (p)
ControlTestSignificanceControlTestSignificance
OSDI43.0±14.443.9±13.40.3639.8±12.720.7±8.7<0.001*<0.001*
Meibomian gland quality2.40±1.092.35±0.990.762.05±1.231.3±0.92<0.05*<0.001*
Meibomian gland expressibilty2.00±1.082.15±0.890.261.70±1.031.35±0.82<0.05*<0.001*
Meibomian gland drop-out2.80±1.242.90±1.250.412.65±1.042.05±1.15<0.05*<0.05*
Osmolarity (mOsm/L)310.3±10.6310.9±9.50.43308.9±11.6305.0±9.1<0.05*<0.001*
Lipid layer thickness2.10±0.722.05±0.890.662.2±0.623.1±0.91<0.05*<0.001*
Tear film stability (s)9.29±3.649.48±3.740.129.32±3.5611.37±3.45<0.001*<0.001*
Tear film meniscus height (mm)0.34±0.060.34±0.070.690.34±0.060.36±0.06<0.001*<0.05*
Visual acuity (LogMAR)−0.04±0.03−0.04±0.030.79−0.05±0.03−0.05±0.030.420.06
Corneal topography (e)0.37±0.150.37±0.160.890.37±0.150.37±0.170.910.65
Conjunctival hyperaemia vessel coverage1.86±1.521.61±1.190.281.44±1.060.94±0.65<0.05*<0.05*
Conjunctival hyperaemia coloration38.81±1.6238.53±1.660.2338.49±1.4238.00±1.41<0.05*<0.05*
Ocular surface staining3.2±2.063.75±1.710.072.95±1.391.85±0.99<0.05*<0.001*
  • Asterisks (*) represent statistical significance. Note: conjunctival vessel coverage and colouration an average of superior, inferior, nasal and temporal quadrants as the effect was similar across ocular surface regions.