Table 3.
Summary of Major Adverse Events Associated with the Topical Administration of 0.002% Omidenepag Isopropyl Ophthalmic Solution Once-Daily in Clinical Trials
| Reference | NCT Number (Trial Feature) | Subjects Analyzed, n | Major AEs Occurring at a Frequency of 1% or More | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Conjunctival Hyperemia, n (%) | Corneal Thickening, n (%) | Macular Edema/Cystoid Macular Edema, n (%) | Eye Pain, n (%) | Photophobia, n (%) | Blurred Vision, n (%) | Cells in the Anterior Chamber, n (%) | |||
| Total | 360 | 71 (19.7) | 18 (5.0) | 16 (4.4) | 13 (3.6) | 12 (3.3) | 6 (1.7) | 5 (1.4) | |
| Aihara et al. J Glaucoma, 2019 | NCT01868126 | 14 | 2 (14.3) | NA | NA | 2 (14.3) | 2 (14.3) | NA | NA |
| Aihara et al. J Glaucoma, 2019 | NCT02179008 (SEE-1) | 29 | 5 (17.2) | NA | NA | 2 (6.9) | 4 (13.8) | NA | NA |
| Aihara et al. J Glaucoma, 2019 | NCT02623738 (AYAME) | 22 | 5 (22.7) | 2 (9.1) | NA | NA | NA | NA | NA |
| Aihara et al. Am J Ophthalmol, 2020 | NCT02623738 (AYAME) | 94 | 23 (24.5) | 11 (11.7) | NA | 4 (4.3) | 4 (4.3) | 2 (2.1) | NA |
| Aihara et al, Jpn J Ophthalmol, 2020 | NCT02822742 (FUJI) | 26 | 2 (7.7) | NA | NA | NA | NA | NA | 2 (7.7) |
| Aihara et al, Jpn J Ophthalmol, 2021 | NCT02822729 (RENGE, Cohort 1) | 48 | 8 (16.7) | 0 (0.0) | 8 (16.7) | 2 (4.2) | NA | 1 (2.1) | 2 (4.2) |
| Aihara et al, Jpn J Ophthalmol, 2021 | NCT02822729 (RENGE, Cohort 2) | 37 | 8 (21.6) | 2 (5.4) | 2 (5.4) | 0 (0.0) | NA | 1 (2.7) | 0 (0.0) |
| Aihara et al, Jpn J Ophthalmol, 2021 | NCT02822729 (RENGE, Cohort 3) | 40 | 18 (45.0) | 3 (7.5) | 6 (15.0) | 3 (7.5) | NA | 2 (5.0) | 1 (2.5) |
| Olander et al. J Glaucoma, 2021 | NCT03858894 (SPECTRUM 6) | 50 | 0 (0.0) | NA | NA | NA | 2 (4.0) | NA | NA |
Abbreviations: NCT, national clinical trial; AE, adverse event; n, number of subjects; NA, not applicable.