Table 3.
AE category (MedDRA PT presented by SOC), n (%) | Olopatadine HCl 0.77% (n=164) | Olopatadine 0.2% (n=167) | Vehicle (n=117) |
---|---|---|---|
Eye disorders | |||
Eye irritation | 2 (1.2) | 0 | 1 (0.9) |
Vision blurred | 0 | 1 (0.6) | 2 (1.7) |
VA reduced | 2 (1.2) | 1 (0.6) | 0 |
Infections and infestations | |||
Gastroenteritis viral | 3 (1.8) | 0 | 0 |
Nervous system disorders | |||
Dysgeusia | 2 (1.2) | 0 | 0 |
Respiratory, thoracic, and mediastinal disorders | |||
Cough | 0 | 0 | 2 (1.7) |
Note: Olopatadine HCl 0.77% refers to olopatadine HCl 0.77% (equivalent to 0.7% olopatadine free base) treatment group.
Abbreviations: AEs, adverse events; MedDRA, Medical Dictionary for Regulatory Activities; PT, preferred term; SOC, system organ class; VA, visual acuity.