Table 4 Summary of adverse events excluding conjunctival hyperemia
AE | Number (%) | |||
|---|---|---|---|---|
Week 1 N = 250 | Month 1 N = 232 | Month 3 N = 212 | Over the study N = 250 | |
Eyelash growth | 4 (1.6%) | 16 (6.9%) | 17 (8.0%) | 23 (9.2%) |
Skin pigmentation | 5 (2.0%) | 11 (4.7%) | 12 (5.7%) | 16 (6.4%) |
Ocular pruritus | 5 (2.0%) | 9 (3.9%) | 3 (1.4%) | 12 (4.8%) |
Foreign body sensation | 6 (2.4%) | 6 (2.6%) | 1 (0.5%) | 11 (4.4%) |
Dry eyes | 5 (2.0%) | 6 (2.6%) | 1 (0.5%) | 9 (3.6%) |
Conjunctivitis | 1 (0.4%) | 2 (0.9%) | 1 (0.5%) | 3 (1.2%) |
Eye swelling pain | 3 (1.2%) | Â | 1 (0.5%) | 4 (1.6%) |
Lachrymation | 2 (0.8%) | Â | Â | 2 (0.8%) |
Ocular burning sensation | 1 (0.4%) | 1 (0.4%) | Â | 2 (0.8%) |
Eye sore | 1 (0.4%) | Â | Â | 1 (0.4%) |
Ocular stinging | 2 (0.8%) | 1 (0.4%) | Â | 3 (1.2%) |
Ocular abnormal sensation | Â | 1 (0.4%) | Â | 1 (0.4%) |
Ocular discharge | 1 (0.4%) | 1 (0.4%) | Â | 2 (0.8%) |
Heavy feeling in eyelids | Â | 1 (0.4%) | Â | 1 (0.4%) |
Corneal epithelial ulcer | Â | 1 (0.4%) | Â | 1 (0.4%) |
Trichiasis | Â | Â | 1 (0.5%) | 1 (0.4%) |
Conjunctival follicle | Â | 1 (0.4%) | Â | 1 (0.4%) |
Subconjunctival hemorrhage | 1 (0.4%) | Â | Â | 1 (0.4%) |
Slight visual acuity reduction | 1 (0.4%) | Â | Â | 1 (0.4%) |
Fatigue | 1 (0.4%) | Â | Â | 1 (0.4%) |
Headache | 2 (0.8%) | Â | 1 (0.5%) | 2 (0.8%) |
Whole-body pruritus | Â | Â | 1 (0.5%) | 1 (0.4%) |
Overall | 28 (11.2%) | 38 (16.4%) | 32 (15.1%) | 59 (23.6%) |