Rochester Ophthalmological Group, Rochester, New York.
Great Lakes Eye Care, St Joseph, Michigan.
Ophthalmol Glaucoma. 2023 Mar-Apr;6(2):198-205. doi: 10.1016/j.ogla.2022.08.015. Epub 2022 Aug 31.
To perform a phase Ⅰ/Ⅱ evaluation of an H-1337 ophthalmic solution in subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).
This was a phase I/II, randomized, double-masked, vehicle-controlled, dose-response study conducted at 6 private practice sites in the United States. The study was registered with clinicaltrials.gov as NCT03452033.
Eighty-seven subjects with bilateral POAG or OHT were enrolled.
After washout of ocular hypotensive medications as required, the subjects were randomized to receive either the H-1337 ophthalmic solution at 0.06%, 0.2%, and 0.6% or its vehicle twice daily unilaterally in the study eye for the first 3 days and then twice daily in both eyes from day 4 to 28.
The primary efficacy end point was the mean change in intraocular pressure from baseline (day 0) for each group on day 28 at hour 4 compared with the vehicle.
In the primary efficacy end point, i.e., mean change from the baseline on day 28 at hour 4, the mean change from the baseline was - 4.45 ± 3.801, - 5.16 ± 3.114, - 4.93 ± 3.110, and - 0.39 ± 2.355 in the 0.06%, 0.2%, and 0.6% H-1337 and vehicle groups, respectively. The difference between each active group and the vehicle group was statistically significant (P < 0.0001). Treatment-emergent adverse events (TEAEs) occurred in 49% of subjects who received H-1337 (range, 41% [0.2% arm]-64% [0.6% arm] across the H-1337 arms) and 18% of subjects who received the vehicle. The majority of TEAEs were mild in severity; 3 subjects who received H-1337 had a TEAE of moderate intensity (instillation site erythema, blurred vision, and muscle strain).
The H-1337 ophthalmic solution showed clinically and statistically significant ocular hypotensive activity and was well tolerated, with a relatively low incidence of hyperemia.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
评估 H-1337 滴眼液在原发性开角型青光眼（POAG）或高眼压症（OHT）患者中的 I/II 期疗效。
这是一项在美国 6 家私人诊所进行的 I/II 期、随机、双盲、对照、剂量反应研究。该研究已在 clinicaltrials.gov 上注册，编号为 NCT03452033。
共纳入 87 例双侧 POAG 或 OHT 患者。
在根据需要停用降眼压药物的洗脱期后，患者被随机分配至研究眼接受 H-1337 滴眼液 0.06%、0.2%和 0.6%或其赋形剂，每日 2 次，连续 3 天单侧给药，然后从第 4 天至第 28 天每日 2 次双眼给药。
主要疗效终点为各组在第 28 天第 4 小时与基线（第 0 天）相比的平均眼压变化。
在主要疗效终点（即第 28 天第 4 小时的平均基线变化）中，0.06%、0.2%和 0.6%H-1337 组及赋形剂组的平均基线变化分别为-4.45±3.801、-5.16±3.114、-4.93±3.110 和-0.39±2.355。与赋形剂组相比，各活性药物组的差异均有统计学意义（P<0.0001）。接受 H-1337 治疗的患者中有 49%（范围为 41%[0.2% 组]至 64%[0.6% 组]）出现治疗中出现的不良事件（TEAE），接受赋形剂治疗的患者中有 18%出现 TEAE。大多数 TEAEs 为轻度；3 例接受 H-1337 治疗的患者出现中度强度的 TEAE（滴眼部位红斑、视力模糊和肌肉紧张）。
H-1337 滴眼液具有临床和统计学显著的降眼压作用，且耐受性良好，红斑发生率相对较低。
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