Table S2.
Overall summary of treatment-related AEs occurring at an incidence of ≥1% by treatment (safety population)
| AEs (MedDRA PT), n (%) | Olopatadine 0.77% (n=330) |
Vehicle (n=169) |
|---|---|---|
| Total | 53 (16.1) | 31 (18.3) |
| Ocular AEs | ||
| Vision blurred | 15 (4.5) | 7 (4.1) |
| Dry eye | 8 (2.4) | 5 (3.0) |
| Abnormal sensation in the eye | 7 (2.1) | 7 (4.1) |
| Corneal staining* | 8 (2.4) | 7 (4.1) |
| Conjunctival staining* | 6 (1.8) | 1 (0.6) |
| Eye pruritus | 2 (0.6) | 1 (0.6) |
| Eye pain | 3 (0.9) | 0 |
| Eye irritation | 1 (0.3) | 5 (3.0) |
| Ocular hyperemia | 2 (0.6) | 0 |
| Conjunctival hemorrhage | 0 | 0 |
| Non-ocular AEs | ||
| Headache | 3 (0.9) | 1 (0.6) |
| Dysgeusia | 8 (2.4) | 0 |
| Upper respiratory tract infection | 0 | 0 |
| Nasopharyngitis | 0 | 0 |
| Influenza | 0 | 0 |
| Pyrexia | 0 | 0 |
| Sinus congestion | 0 | 0 |
| Skin discoloration | 1 (0.3) | 0 |
| Ligament sprain | 0 | 0 |
| Hypertension | 0 | 0 |
Notes:
*
All of the adverse drug reactions of corneal staining and conjunctival staining were reported by one investigator who conducted fluorescein staining at some post-dose visits. Fluorescein staining was not a protocol required procedure and was not conducted at baseline (screening visits) for any subjects. Olopatadine 0.77%, olopatadine hydrochloride solution 0.77%; vehicle, olopatadine hydrochloride solution 0.77% vehicle.
Abbreviations: AE, adverse event; MedDRA, medical dictionary for the regulatory activities; PT, preferred term.