Table 3.
Blood Chemistry of Dutch Belted Rabbits Following 21 Days of Topical Ophthalmic Administration of QLS-101
| Males |
|||||
|---|---|---|---|---|---|
| Vehicle | QLS-101 (0.8 mg/eye/dose) | QLS-101 (1.6 mg/dose/eye) | QLS-101 (3.2 mg/eye/dose) | Historical control range | |
| Aspartate aminotransferase (U/L) | 21.20 ± 3.00 | 22.70 ± 12.40 | 17.00 ± 0.00 | 18.40 ± 2.80 | 15.10–67.60 |
| Alanine aminotransferase (U/L) | 28.80 ± 7.90 | 40.00 ± 8.50 | 23.00 ± 5.30 | 29.40 ± 8.60 | 16.60–53.70 |
| Alkaline phosphatase (U/L) | 88.60 ± 13.50 | 106.70 ± 27.70 | 93.70 ± 3.50 | 106.00 ± 24.80 | 43.70–155.10 |
| Total bilirubin (mg/dL) | 0.04 ± 0.02 | 0.03 ± 0.03 | 0.02 ± 0.02 | 0.03 ± 0.02 | 0.00–0.05 |
| Urea nitrogen (mg/dL) | 19.00 ± 2.30 | 16.70 ± 1.20 | 19.00 ± 2.60 | 17.60 ± 2.70 | 14.10–23.80 |
| Creatinine (mg/dL) | 0.80 ± 0.07 | 0.83 ± 0.06 | 0.87 ± 0.15 | 0.84 ± 0.05 | 0.70–1.05 |
| Creatinine kinase (U/L) | 687.00 ± 237.60 | 475.70 ± 86.50 | 436.00 ± 144.50 | 488.00 ± 116.80 | 428.50–29,866.30 |
| Glucose (mg/dL) | 120.60 ± 2.40 | 129.70 ± 8.50 | 118.70 ± 7.40 | 126.20 ± 11.70 | 118.00–148.50 |
| Cholesterol (mg/dL) | 22.60 ± 1.70 | 21.30 ± 2.30 | 29.30 ± 8.50 | 25.40 ± 5.50 | 21.00–47.10 |
| Triglycerides (mg/dL) | 35.40 ± 8.30 | 36.00 ± 5.20 | 34.00 ± 7.20 | 40.80 ± 13.90 | 23.70–51.90 |
| Total protein (g/dL) | 5.70 ± 0.10 | 5.73 ± 0.06 | 5.90 ± 0.10 | 5.72 ± 0.19 | 5.46–6.20 |
| Albumin/globulin ratio (G) | 3.52 ± 0.34 | 3.47 ± 0.12 | 3.10 ± 0.20 | 3.40 ± 0.25 | 2.81–3.79 |
| Calcium (mg/dL) | 13.44 ± 0.28 | 13.67 ± 0.21 | 13.50 ± 0.26 | 13.70 ± 0.54 | 11.89–14.08 |
| Phosphorus (mg/dL) | 5.44 ± 0.11 | 5.13 ± 0.46 | 5.67 ± 0.15 | 5.44 ± 0.40 | 4.70–6.35 |
| Sodium (mmol/L) | 138.60 ± 1.10 | 139.30 ± 1.20 | 140.30 ± 0.60 | 139.80 ± 0.80 | 137.60–144.00 |
| Potassium (mmol/L) | 4.40 ± 0.22 | 4.30 ± 0.26 | 4.37 ± 0.25 | 4.40 ± 0.39 | 4.16–5.66 |
| Chloride (mmol/L) | 103.20 ± 1.50 | 102.00 ± 1.70 | 103.30 ± 0.60 | 102.40 ± 1.90 | 99.00–105.00 |
| |
Females |
||||
|---|---|---|---|---|---|
| Vehicle | QLS-101 (0.8 mg/eye/dose) | QLS-101 (1.6 mg/eye/dose) | QLS-101 (3.2 mg/eye/dose) | Historical control range | |
| Aspartate aminotransferase (U/L) |
21.60 ± 6.50 |
19.30 ± 2.50 |
16.00 ± 4.40 |
17.40 ± 3.10 |
13.00–49.10 |
| Alanine aminotransferase (U/L) |
34.40 ± 9.30 |
29.00 ± 7.00 |
20.70 ± 7.20 |
25.00 ± 5.80 |
19.00–52.00 |
| Alkaline phosphatase (U/L) |
109.20 ± 19.00 |
90.00 ± 10.40 |
86.70 ± 24.80 |
80.00 ± 11.40 |
65.10–162.30 |
| Total bilirubin (mg/dL) |
0.02 ± 0.02 |
0.04 ± 0.01 |
0.03 ± 0.03 |
0.02 ± 0.02 |
0.00–0.06 |
| Urea nitrogen (mg/dL) |
25.40 ± 3.8 0 |
25.70 ± 2.10 |
22.30 ± 3.20 |
23.40 ± 4.30 |
13.10–28.80 |
| Creatinine (mg/dL) |
0.88 ± 0.08 |
1.03 ± 0.12 |
0.93 ± 0.06 |
0.90 ± 0.07 |
0.70–1.10 |
| Creatinine kinase (U/L) |
515.60 ± 70.40 |
417.00 ± 100.30 |
452.00 ± 200.10 |
470.00 ± 109.60 |
371.50–28,004.60 |
| Glucose (mg/dL) |
117.00 ± 8.20 |
122.70 ± 11.20 |
122.70 ± 9.90 |
121.20 ± 12.3 |
109.20–142.00 |
| Cholesterol (mg/dL) |
35.20 ± 2.70 |
40.70 ± 2.90 |
38.00 ± 3.50 |
38.80 ± 9.30 |
31.00–60.80 |
| Triglycerides (mg/dL) |
33.40 ± 3.30 |
38.70 ± 8.10 |
35.00 ± 1.00 |
35.80 ± 9.00 |
24.10–45.90 |
| Total protein (g/dL) |
5.70 ± 0.37 |
5.90 ± 0.20 |
5.80 ± 0.35 |
5.68 ± 0.35 |
5.20–6.60 |
| Albumin/globulin ratio (G) |
3.26 ± 0.18 |
3.10 ± 0.20 |
3.17 ± 0.55 |
3.34 ± 0.44 |
2.40–3.98 |
| Calcium (mg/dL) |
13.32 ± 0.40 |
13.50 ± 0.26 |
13.40 ± 0.20 |
13.50 ± 0.43 |
12.41–13.90 |
| Phosphorus (mg/dL) |
5.00 ± 0.22 |
5.17 ± 0.25 |
4.70 ± 0.26 |
5.08 ± 0.23 |
4.50–5.99 |
| Sodium (mmol/L) |
138.20 ± 1.10 |
139.70 ± 1.20 |
138.00 ± 2.00 |
138.20 ± 0.80 |
136.00–144.00 |
| Potassium (mmol/L) |
4.46 ± 0.26 |
4.10 ± 0.10 |
4.10 ± 0.10 |
4.36 ± 0.17 |
3.90–4.90 |
| Chloride (mmol/L) | 102.40 ± 1.80 | 102.30 ± 2.10 | 101.70 ± 1.50 | 101.20 ± 2.30 | 99.0 0–105.00 |