Table 3. Summary of Treatment-Emergent Adverse Events (TEAEs) Over the 29-Day Treatment Duration.
TEAEs | No. (%) | |
---|---|---|
Cyclosporine (nā=ā103) | Vehicle (nā=ā103) | |
All causality | ||
TEAEs, No. | 56 | 41 |
Participants with at least 1 TEAE | 35 (34.0) | 31 (30.1) |
Ocular TEAEs | 42 | 27 |
Participants with at least 1 ocular TEAE | 26 (25.2) | 22 (21.4) |
Treatment-related | ||
TEAEs, No. | 21 | 11 |
Participants with at least 1 TEAE | 15 (14.6) | 11 (10.7) |
Ocular TEAEs | 21 | 11 |
Participants with at least 1 ocular TEAE | 15 (14.6) | 11 (10.7) |
Ocular TEAEs that occurred in >2% of study participants in either group | ||
Visual acuity reduced | 13 (12.6) | 18 (17.5) |
Ocular discomfort | 4 (3.9) | 2 (1.9) |
Eye pain | 3 (2.9) | 2 (1.9) |
Vision blurred | 3 (2.9) | 2 (1.9) |
Instillation site reactions | 3 (2.9) | 0 |