Adverse events/device deficiencies (mITT population)
| Test 1 (n=88) | Test 2 (n=75) | Control (n=93) | |
| Ocular AEs, n (%) | |||
| Blepharitis | 6 (6.8) | 0 (0) | 2 (2.1) |
| Conjunctivitis | 0 (0) | 2 (2.7) | 0 (0) |
| Headache | 0 (0) | 0 (0) | 3 (3.2) |
| Hordeolum | 1 (1.1) | 0 (0) | 1 (1.1) |
| Lattice | 1 (1.1) | 0 (0) | 0 (0) |
| Operculated retinal hole | 0 (0) | 1 (1.3) | 0 (0) |
| Reduction in VA | 0 (0) | 0 (0) | 1 (1.1) |
| Skin irritation | 1 (1.1) | 0 (0) | 0 (0) |
| Trauma to eye | 0 (0) | 1 (1.3) | 0 (0) |
| Non-ocular, non-device-related AEs, n (%) | 13 (14.8) | 13 (17.3) | 14 (15.1) |
| Device deficiencies, n (%) | |||
| Total | 12 (13.6) | 31 (41.3) | 12 (12.9) |
| Issue with lens | 4 (4.5) | 11 (14.7) | 1 (1.1) |
| Misaligned optical centre | 2 (2.3) | 6 (8.0) | 0 (0) |
| Scratched lenses | 2 (2.3) | 2 (2.7) | 0 (0) |
| Issue with lens edge | 0 (0) | 2 (2.7) | 0 (0) |
| Wrong prescription | 0 (0) | 0 (0) | 1 (1.1) |
| Issue with frame | 8 (9.1) | 19 (25.3) | 11 (11.8) |
| Broken frame and scratched lens | 0 (0) | 1 (1.3) | 0 (0) |
AE, adverse event; mITT, modified intention-to-treat; VA, visual acuity.