TABLE 2.
Preoperative Ocular Characteristics: Overall Trial Population, Failed-Surgery Subgroup, MTMT Subgroup*
| Parameter | Overall Trial Population N=72 | Failed-Surgery Subgroup N=61 | MTMT Subgroup N=11 |
|---|---|---|---|
| Visual field mean deviation (MD) at screening (dB) | |||
| Mean | −14.44 | −15.10 | −10.67 |
| SD | 8.64 | 8.56 | 8.56 |
| Visual field MD at screening†, n (%) | |||
| VF MD −12 to 0 dB | 31 (43.1) | 24 (39.3) | 7 (63.6) |
| VF MD −20 to worse than −12 dB | 16 (22.2) | 15 (24.6) | 1 (9.1) |
| VF MD worse than −20 dB | 25 (34.7) | 18 (29.5) | 2 (18.2) |
| Shaffer angle grade at screening, n (%) | |||
| III (≥25 and <35) | 24 (33.3) | 21 (34.4) | 3 (27.3) |
| IV (≥35) | 48 (66.7) | 40 (65.6) | 8 (72.7) |
| Glaucoma treatment history at screening, n (%) | |||
| Primary open angle glaucoma | 55 (76.4) | 55 (90.2) | 10 (90.9) |
| Pseudoexfoliative glaucoma | 3 (4.2) | 3 (4.9) | 0 (0.0) |
| Pigmentary glaucoma | 3 (4.2) | 3 (4.9) | 0 (0.0) |
| Glaucoma secondary to elevated episcleral venous pressure | 1 (1.4) | 0 | 1 (9.1) |
| Lens status, n (%) | |||
| Phakic | 6 (8.3) | 3 (4.9) | 3 (27.3) |
| Pseudophakic | 66 (91.7) | 58 (95.1) | 8 (72.7) |
| Diurnal medicated IOP at baseline (mm Hg) | |||
| Mean (SD) | 23.4 (2.8) | 23.5 (2.8) | 22.8 (2.6) |
| Range | 20–35 | 20–35 | 20–29 |
| No. ocular hypotensive medication classes at baseline, n (%) | |||
| 1–2 | 19 (26.4) | 19 (31.1) | 0 (0.0) |
| 3 | 26 (36.1) | 26 (42.6) | 0 (0.0) |
| ≥4 | 27 (37.5) | 16 (26.2) | 11 (100.0) |
| Mean (SD) | 3.1 (0.9) | 3.0 (0.9) | 4.1 (0.3) |
| Ocular hypotensive medication class at baseline, n (%) | |||
| Alpha agonist | 40 (55.6) | 30 (49.2) | 10 (90.9) |
| Beta blocker | 59 (81.9) | 49 (80.3) | 11 (100.0) |
| Carbonic anhydrase inhibitor | 53 (73.6) | 43 (70.5) | 11 (100.0) |
| Carbonic anhydrase inhibitor (oral) | 3 (4.2) | 3 (4.9) | 0 (0.0) |
| Prostaglandin analogue | 62 (86.1) | 50 (82.0) | 11 (100.0) |
| Rho kinase inhibitor | 6 (8.3) | 5 (8.2) | 2 (18.2) |
| Miotics | 1 (1.4) | 1 (1.6) | 0 (0.0) |
| BSCVA at baseline, n (%) | |||
| 20/20 or better | 15 (20.8) | 13 (21.3) | 2 (18.2) |
| 20/25 or better | 31 (43.1) | 25 (41.0) | 6 (54.5) |
| 20/32 or better | 43 (59.7) | 37 (60.7) | 6 (54.5) |
| 20/40 or better | 55 (76.4) | 46 (75.4) | 9 (81.8) |
| Worse than 20/40 | 17 (23.6) | 15 (24.6) | 2 (18.2) |
Oral medications count as 1 medication. Combination medications count as 2 medications. For medication class, subjects are counted once for each class of medication taken.
*
Data from intent-to-treat population for all groups.
†
There were 5 subjects with visual fields not measured at screening (not required if BSCVA 20/100 or worse).