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Table 4 Clinician’s Global Evaluation of Treatment: End of Week 12†

From: Efficacy and safety of 0.05% micellar nano-particulate (MNP) cyclosporine ophthalmic emulsion in the treatment of moderate-to-severe keratoconjunctivitis sicca: a 12-week, multicenter, randomized, active-controlled trial

 

ITT population

PP population

Treatment group

A

B

C

A

B

C

Number of eyes graded

96

98

96

60

64

56

Completely cleared

14 (14.6%)

2 (2.0%)

4 (4.2%)

14 (23.3%)

2 (3.1%)

4 (7.1%)

~ 90% improvement

21 (21.9%)

23 (23.5%)

21 (21.9%)

19 (31.7%)

23 (35.9%)

17 (30.3%)

~ 75% improvement

11 (11.5%)

18 (18.4%)

29 (30.2%)

9 (15.0%)

16 (25.0%)

21 (37.5%)

~ 50% improvement

13 (13.5%)

17 (17.3%)

11 (11.5%)

13 (21.7%)

17 (26.6%)

11 (19.6%)

~ 25% improvement

3 (3.1%)

3 (3.1%)

3 (3.1%)

3 (5.0%)

3 (4.7%)

3 (5.4%)

Condition unchanged

2 (2.1%)

3 (3.1%)

0 (0.0%)

2 (3.3%)

3 (4.7%)

0 (0.0%)

Condition worsened

0 (0.0%)

0 (0.0%)

0 (0.0%)

0 (0.0%)

0 (0.0%)

-

P-Value 1

0.1576

0.3075

-

0.1760

0.4363

-

P-Value 2

0.0278

-

-

0.0364

-

-

  1. † Last observation was carried forward in case of missing data in the ITT population.
  2. 1 Wilcoxon’s rank sum test: test groups vs. control
  3. 2 Wilcoxon’s rank sum test: test group A vs. test group B