Table 2 Effect on Ocular Surface Disease Activity
ITT population | PP population | |||||
|---|---|---|---|---|---|---|
Treatment group | A | B | C | A | B | C |
Number of eyes | 96 | 98 | 96 | 60 | 64 | 56 |
Restoration of corneal surface integrity: Corneal Fluorescein Staining Scores (CFSS) | ||||||
Mean score at baseline (± SD) | 8.7 (3.4) | 9.5 (3.5) | 8.7 (3.6) | 8.9 (3.0) | 9.5 (3.3) | 8.5 (3.1) |
Mean score at 12 weeks (± SD) | 3.3 (3.4) | 3.9 (3.0) | 4.5 (2.9) | 2.2 (2.2) | 3.8 (3.4) | 3.9 (3.2) |
Mean change from baseline (± SD) | − 5.3 (4.1) | − 5.6 (3.8) | − 4.4 (3.7) | − 6.8 (4.0) | − 5.7 (3.9) | − 4.6 (3.6) |
P value† (test groups vs. control) | 0.0912 | 0.0247 | - | 0.0026 | 0.1101 | - |
P value† (A vs. B) | 0.6475 | - | - | 0.1329 | - | - |
ANCOVA‡ P value | 0.0142 | 0.0641 | - | 0.0007 | 0.4101 | - |
Effect on tear formation: Shirmer Tear Test Values (STT) | ||||||
Mean score at baseline (± SD) | 6.4 (3.0) | 6.7 (3.2) | 6.3 (3.6) | 6.8 (2.9) | 6.6 (3.1) | 5.9 (4.0) |
Mean score at 12 weeks (± SD) | 17.5 (10.5) | 15.9 (9.4) | 15.1 (8.6) | 21.0 (10.3) | 17.3 (9.7) | 15.8 (9.9) |
Mean change from baseline (± SD) | 11.1 (9.9) | 9.2 (8.4) | 8.8 (7.1) | 14.2 (9.9) | 10.7 (8.3) | 10.0 (7.8) |
P value† (test groups vs. control) | 0.0634 | 0.7115 | - | 0.0129 | 0.6483 | - |
P value† (A vs. B) | 0.1457 | - | - | 0.0334 | - | - |
ANCOVA‡ P value | 0.0610 | 0.7302 | - | 0.0120 | 0.7064 | - |
Healing of conjunctival lesions: Conjunctival Lissamine Green Staining (CLGS) | ||||||
Mean score at baseline (± SD) | 9.4 (4.6) | 10.2 (4.4) | 9.7 (4.7) | 10.3 (4.3) | 10.5 (4.1) | 9.5 (3.7) |
Mean score at 12 weeks (± SD) | 4.1 (3.6) | 4.6 (3.3) | 5.0 (4.0) | 3.1 (3.0) | 4.3 (3.3) | 4.8 (4.1) |
Mean change from baseline (± SD) | − 5.3 (5.5) | − 5.5 (4.8) | − 4.8 (5.0) | − 7.2 (5.9) | − 6.2 (4.7) | − 4.7 (5.3) |
P value† (test groups vs. control) | 0.4924 | 0.2736 | - | 0.0203 | 0.1066 | - |
P value† (A vs. B) | 0.7375 | - | - | 0.3251 | - | - |
ANCOVA‡ P value | 0.1094 | 0.3066 | - | 0.0065 | 0.3069 | - |
Patient-reported improvement in disease severity: Ocular Surface Disease Index (OSDI) | ||||||
Number of patients | 48 | 49 | 47 | 30 | 32 | 28 |
Mean score at baseline (± SD) | 54.4 (23.4) | 55.0 (23.2) | 52.5 (26.1) | 56.8 (23.5) | 56.9 (23.6) | 45.9 (21.7) |
Mean score at 12 weeks (± SD) | 22.6 (18.1) | 24.1 (16.3) | 25.2 (12.2) | 17.3 (15.6) | 23.6 (16.8) | 22.3 (11.0) |
Mean change from baseline (± SD) | − 31.8 (27.2) | − 30.9 (24.2) | − 28.0 (25.5) | − 39.5 (28.7) | − 33.3 (22.1) | − 23.6 (21.8) |
P value† (test groups vs. control) | 0.4875 | 0.5757 | - | 0.0217 | 0.0911 | - |
P value† (A vs. B) | 0.8605 | - | - | 0.3464 | - | - |
ANCOVA‡ P value | 0.3644 | 0.6249 | - | 0.0276 | 0.4583 | - |