Introduction
Methods
Study design
Study population
Intervention and follow-up
Outcome measures
Statistical analysis
Results
Study population
Cohort 1 (n = 48) | Cohort 2 (n = 44) | Cohort 3 (n = 41) | Cohort 4a (n = 46) | Total (n = 179) | |
---|---|---|---|---|---|
Age (years) | 59.9 ± 13.8 | 65.3 ± 9.5 | 63.5 ± 10.0 | 65.2 ± 9.1 | 63.4 ± 11.0 |
Sex | |||||
Male | 25 (52.1) | 26 (59.1) | 26 (63.4) | 22 (47.8) | 99 (55.3) |
Female | 23 (47.9) | 18 (40.9) | 15 (36.6) | 24 (52.2) | 80 (44.7) |
Diagnosis | |||||
POAG | 42 (87.5) | 34 (77.3) | 39 (95.1) | 36 (78.3) | 151 (84.4) |
OHT | 6 (12.5) | 8 (18.2) | 2 (4.9) | 10 (21.7) | 26 (14.5) |
EXG | 0 | 2 (4.5) | 0 | 0 | 2 (1.1) |
Pigmentary glaucoma | 0 | 0 | 0 | 0 | 0 |
Baseline IOPb (mmHg) | |||||
At 09:00 | 17.5 ± 1.7 | 18.8 ± 3.5 | 17.6 ± 1.9 | 19.1 ± 3.3 | 18.2 ± 2.8 |
At 11:00 | 16.5 ± 2.0 | 17.5 ± 3.3 | 16.0 ± 2.1 | 17.4 ± 3.0 | 16.8 ± 2.7 |
Previous treatmentc | |||||
Yes | 47 (97.9) | 43 (97.7) | 41 (100.0) | 37 (80.4) | 168 (93.9) |
No | 1 (2.1) | 1 (2.3) | 0 | 9 (19.6) | 11 (6.1) |
Received ripasudil or brimonidine during screening period | |||||
Ripasudil | 0 | 0 | 6 (14.6) | 3 (6.5) | 9 (5.0) |
Brimonidine | 2 (4.2) | 2 (4.5) | 4 (9.8) | 5 (10.9) | 13 (7.3) |
None | 46 (95.8) | 42 (95.5) | 31 (75.6) | 38 (82.6) | 157 (87.7) |
History of allergyd | |||||
Yes | 26 (54.2) | 25 (56.8) | 16 (39.0) | 22 (47.8) | 89 (49.7) |
No | 22 (45.8) | 19 (43.2) | 25 (61.0) | 24 (52.2) | 90 (50.3) |
IOP-lowering effect of RBFC
n | Baseline IOPa (mmHg) | Change in IOP from baselineb,c (mmHg) | |||
---|---|---|---|---|---|
Week 8 | Week 28 | Week 52 | |||
Total study population | 179 | 16.8 ± 2.7 | − 3.7 ± 2.5 | − 3.6 ± 2.7 | − 3.4 ± 3.1 |
Cohort | |||||
Cohort 1 | 48 | 16.5 ± 2.0 | − 3.8 ± 2.1 | − 4.1 ± 2.5 | − 3.5 ± 2.8 |
Cohort 2 | 44 | 17.5 ± 3.3 | − 3.5 ± 3.1 | − 3.5 ± 2.8 | − 3.3 ± 3.4 |
Cohort 3 | 41 | 16.0 ± 2.1 | − 3.2 ± 2.3 | − 3.0 ± 2.5 | − 2.7 ± 3.1 |
Cohort 4 | 46 | 17.4 ± 3.0 | − 4.2 ± 2.5 | − 3.6 ± 2.9 | − 4.1 ± 3.0 |
Cohort 4 (RBFC monotherapy)d | 21 | 19.0 ± 3.2 | − 4.9 ± 2.0 | − 4.3 ± 3.1 | − 5.5 ± 2.5 |
Age | |||||
< 65 years | 86 | 16.5 ± 2.5 | − 3.5 ± 2.3 | − 3.8 ± 2.6 | − 3.4 ± 2.9 |
≥ 65 years | 93 | 17.1 ± 2.9 | − 3.8 ± 2.7 | − 3.3 ± 2.7 | − 3.4 ± 3.3 |
Sex | |||||
Male | 99 | 16.7 ± 2.8 | − 3.7 ± 2.6 | − 3.5 ± 2.9 | − 3.1 ± 3.3 |
Female | 80 | 17.0 ± 2.7 | − 3.7 ± 2.4 | − 3.6 ± 2.5 | − 3.9 ± 2.8 |
Diagnosise | |||||
POAG | 151 | 16.5 ± 2.3 | − 3.6 ± 2.4 | − 3.5 ± 2.5 | − 3.4 ± 3.1 |
OHT | 26 | 19.1 ± 3.6 | − 4.3 ± 3.4 | − 3.8 ± 3.6 | − 3.5 ± 3.3 |
Baseline IOPa | |||||
< 17.5 mmHg | 82 | 15.2 ± 1.6 | − 3.4 ± 2.3 | − 3.4 ± 2.3 | − 3.2 ± 2.8 |
≥ 17.5 mmHg | 97 | 18.2 ± 2.8 | − 4.0 ± 2.7 | − 3.7 ± 3.0 | − 3.6 ± 3.4 |
Concomitant treatment with PG analogue | |||||
Yes | 134 | 16.6 ± 2.6 | − 3.5 ± 2.5 | − 3.5 ± 2.6 | − 3.2 ± 3.1 |
No | 45 | 17.4 ± 3.1 | − 4.1 ± 2.5 | − 3.6 ± 3.0 | − 4.0 ± 3.0 |
Concomitant treatment with β-blocker | |||||
Yes | 102 | 16.6 ± 2.8 | − 3.5 ± 2.8 | − 3.3 ± 2.6 | − 3.1 ± 3.2 |
No | 77 | 17.2 ± 2.7 | − 4.0 ± 2.2 | − 3.9 ± 2.7 | − 3.9 ± 3.0 |
Concomitant treatment with CAI | |||||
Yes | 52 | 15.9 ± 2.1 | − 3.3 ± 2.2 | − 3.2 ± 2.6 | − 2.9 ± 3.1 |
No | 127 | 17.2 ± 2.9 | − 3.8 ± 2.7 | − 3.7 ± 2.7 | − 3.6 ± 3.1 |
Safety of RBFC
Symptoms/Signsa | Adverse events | Adverse drug reactions | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Cohort 1 (n = 48) | Cohort 2 (n = 44) | Cohort 3 (n = 41) | Cohort 4 (n = 46) | Total (n = 179) | Cohort 1 (n = 48) | Cohort 2 (n = 44) | Cohort 3 (n = 41) | Cohort 4 (n = 46) | Total (n = 179) | |
All events | 44 (91.7) | 39 (88.6) | 38 (92.7) | 44 (95.7) | 165 (92.2) | 40 (83.3) | 33 (75.0) | 27 (65.9) | 36 (78.3) | 136 (76.0) |
Conjunctival hyperaemia Transientb | 33 (68.8) | 22 (50.0) | 21 (51.2) | 28 (60.9) | 104 (58.1) | 33 (68.8) | 22 (50.0) | 21 (51.2) | 28 (60.9) | 104 (58.1) |
25 (52.1) | 19 (43.2) | 16 (39.0) | 21 (45.7) | 81 (45.3) | 25 (52.1) | 19 (43.2) | 17 (41.5) | 21 (45.7) | 82 (45.8) | |
Blepharitis | 14 (29.2) | 11 (25.0) | 9 (22.0) | 12 (26.1) | 46 (25.7) | 8 (16.7) | 9 (20.5) | 8 (19.5) | 6 (13.0) | 31 (17.3) |
Allergic conjunctivitis | 9 (18.8) | 8 (18.2) | 11 (26.8) | 10 (21.7) | 38 (21.2) | 8 (16.7) | 8 (18.2) | 8 (19.5) | 9 (19.6) | 33 (18.4) |
Punctate keratitis | 7 (14.6) | 5 (11.4) | 3 (7.3) | 2 (4.3) | 17 (9.5) | 6 (12.5) | 3 (6.8) | 3 (7.3) | 2 (4.3) | 14 (7.8) |
Eye irritation | 6 (12.5) | 2 (4.5) | 2 (4.9) | 3 (6.5) | 13 (7.3) | 6 (12.5) | 2 (4.5) | 2 (4.9) | 3 (6.5) | 13 (7.3) |
Conjunctivitis | 4 (8.3) | 4 (9.1) | 2 (4.9) | 3 (6.5) | 13 (7.3) | 3 (6.3) | 3 (6.8) | 2 (4.9) | 3 (6.5) | 11 (6.1) |
Eye pruritus | 4 (8.3) | 3 (6.8) | 3 (7.3) | 1 (2.2) | 11 (6.1) | 3 (6.3) | 1 (2.3) | 2 (4.9) | 1 (2.2) | 7 (3.9) |
Vision blurred | 3 (6.3) | 1 (2.3) | 0 | 0 | 4 (2.2) | 3 (6.3) | 1 (2.3) | 0 | 0 | 4 (2.2) |
Symptoms/Signsb | Total (n = 179) | ≤ 12 weeks (n = 179) | > 12 to ≤ 24 weeks (n = 173) | > 24 to ≤ 36 weeks (n = 163) | > 36 to ≤ 48 weeks (n = 151) | > 48 weeks (n = 142) |
---|---|---|---|---|---|---|
Conjunctival hyperaemia | 104 (58.1) | 91 (50.8) | 14 (8.1) | 7 (4.3) | 1 (0.7) | 2 (1.4) |
Blepharitis | 46 (25.7) | 8 (4.5) | 10 (5.8) | 14 (8.6) | 11 (7.3) | 4 (2.8) |
Allergic conjunctivitis | 38 (21.2) | 12 (6.7) | 15 (8.7) | 8 (4.9) | 7 (4.6) | 2 (1.4) |
Punctate keratitis | 17 (9.5) | 7 (3.9) | 6 (3.5) | 5 (3.1) | 4 (2.6) | 1 (0.7) |
Eye irritation | 13 (7.3) | 13 (7.3) | 0 | 0 | 0 | 0 |
Conjunctivitis | 13 (7.3) | 4 (2.2) | 6 (3.5) | 3 (1.8) | 2 (1.3) | 0 |
Eye pruritus | 11 (6.1) | 6 (3.4) | 3 (1.7) | 3 (1.8) | 0 | 0 |
Vision blurred | 4 (2.2) | 4 (2.2) | 0 | 0 | 0 | 0 |