TABLE 2.
BIMATOPROST (TP1)/BIMATOPROST (TP2) | VEHICLE (TP1)/BIMATOPROST (TP2) | ||||
---|---|---|---|---|---|
SYSTEM ORGAN CLASS PREFERRED TERM | 0 TO 12 MONTHS (n=96) | 0 TO 6 MONTHS (n=96) | 6 TO 12 MONTHS (n=89) | 0 TO 6 MONTHS (n=33) | 6 TO 12 MONTHS (n=32) |
Any adverse event | 71 (74.0) | 55 (57.3) | 46 (51.7) | 15 (45.5) | 17 (53.1) |
Eye disorders | |||||
Conjunctival hyperemia | 16 (16.7) | 15 (15.6) | 1 (1.1) | 1 (3.0) | 3 (9.4) |
Punctate keratitis | 9 (9.4) | 8 (8.3) | 1 (1.1) | 2 (6.1) | 1 (3.1) |
Eye pruritus | 6 (6.3) | 5 (5.2) | 1 (1.1) | 0 (0) | 1 (3.1) |
Skin and subcutaneous disorders | |||||
Skin hyperpigmentation | 5 (5.2) | 3 (3.1) | 2 (2.2) | 0 (0) | 0 (0) |
Infections and infestations | |||||
Upper respiratory tract infection | 5 (5.2) | 2 (2.1) | 3 (3.4) | 1 (3.0) | 3 (9.4) |
Sinusitis | 5 (5.2) | 1 (1.0) | 5 (5.6) | 0 (0) | 0 (0) |
Nasopharyngitis | 3 (3.1) | 0 (0) | 3 (3.4) | 1 (3.0) | 2 (6.3) |
Bronchitis | 2 (2.1) | 2 (2.1) | 0 (0) | 0 (0) | 2 (6.3) |
Endocrine disorders | |||||
Hypothyroidism | 1 (1.0) | 1 (1.0) | 0 (0) | 0 (0) | 2 (6.3) |
TP=treatment period