Table 1 Tolerability evaluation at baseline, 4, and 12 weeks in the safety set group.

From: A randomized multicenter evaluation of the efficacy of 0.15% hyaluronic acid versus 0.05% cyclosporine A in dry eye syndrome

 

Symptom score (mean ± SD) (%)

0.15% HA

0.05% CsA + 0.5% CMC

0.15% HA + 0.05% CsA

 

P valuea

 

P valueb

Stinging/burning

Baseline

0.43 ± 0.70

0.40 ± 0.68

 

0.35 ± 0.68

 

4 weeks

0.47 ± 0.66

1.10 ± 0.93

 < 0.0001

0.94 ± 0.96

 < 0.0001

12 weeks

0.39 ± 0.69

0.87 ± 0.86

0.0002

0.69 ± 0.89

0.0060

Sticky eye sensation

Baseline

0.20 ± 0.50

0.23 ± 0.54

 

0.17 ± 0.44

 

4 weeks

0.36 ± 0.65

0.45 ± 0.65

0.3221

0.28 ± 0.57

0.4309

12 weeks

0.28 ± 0.56

0.40 ± 0.67

0.1760

0.25 ± 0.52

0.7357

Itching

Baseline

0.39 ± 0.76

0.35 ± 0.67

 

0.30 ± 0.67

 

4 weeks

0.47 ± 0.76

0.34 ± 0.63

0.3858

0.33 ± 0.65

0.7635

12 weeks

0.38 ± 0.67

0.35 ± 0.64

0.8181

0.28 ± 0.54

0.8918

Blurred vision

Baseline

0.57 ± 0.84

0.58 ± 0.81

 

0.45 ± 0.81

 

4 weeks

0.73 ± 0.88

0.86 ± 0.86

0.3045

0.54 ± 0.78

0.8006

12 weeks

0.61 ± 0.82

0.79 ± 0.72

0.0326

0.50 ± 0.71

0.4671

Sandiness/Grittiness

Baseline

0.47 ± 0.79

0.38 ± 0.71

 

0.40 ± 0.73

 

4 weeks

0.50 ± 0.71

0.61 ± 0.80

0.1320

0.55 ± 0.81

0.3482

12 weeks

0.44 ± 0.72

0.49 ± 0.72

0.1766

0.40 ± 0.63

0.4453

Dryness

Baseline

0.84 ± 1.04

0.81 ± 1.04

 

0.63 ± 0.95

 

4 weeks

0.67 ± 0.88

0.68 ± 0.89

0.5843

0.55 ± 0.89

0.3616

12 weeks

0.67 ± 0.91

0.60 ± 0.82

0.9127

0.51 ± 0.73

0.3689

Light sensitivity

Baseline

0.37 ± 0.69

0.42 ± 0.79

 

0.37 ± 0.75

 

4 weeks

0.35 ± 0.68

0.36 ± 0.71

0.6615

0.33 ± 0.63

0.6518

12 weeks

0.30 ± 0.60

0.45 ± 0.77

0.2620

0.26 ± 0.52

0.7952

Pain or soreness

Baseline

0.22 ± 0.58

0.24 ± 0.52

 

0.16 ± 0.43

 

4 weeks

0.26 ± 0.55

0.58 ± 0.79

0.0008

0.53 ± 0.78

0.0002

12 weeks

0.20 ± 0.50

0.43 ± 0.73

0.0394

0.41 ± 0.71

0.0062

  1. A score of 0 = no symptoms, a score of 4 = always had symptoms.
  2. SD standard deviation, HA hyaluronic acid, CsA cyclosporine A, CMC carboxymethylcellulose.
  3. aDifference between the 0.15% HA and 0.05% CsA + 0.5% CMC group (Wilcoxon rank sum test).
  4. bDifference between the 0.15% HA and 0.15% + 0.05% CsA group (Wilcoxon rank sum test).
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