Palacio-Pastrana Claudia, Chávez-Mondragón Eduardo, Soto-Gómez Abraham, Suárez-Velasco Rubén, Montes-Salcedo Miguel, Fernández de Ortega Lourdes, Nasser-Nasser Linda, Baiza-Durán Leopoldo, Olvera-Montaño Oscar, Muñoz-Villegas Patricia
Fundación Hospital Nuestra Señora de la Luz, IAP, CDMX, Mexico.
Fundación de Asistencia Privada Conde de Valenciana, IAP, CDMX, Mexico.
Clin Ophthalmol. 2020 Jun 12;14:1581-1589. doi: 10.2147/OPTH.S254705. eCollection 2020.
The purpose of this study was to compare the efficacy and safety of difluprednate 0.05% (PRO-145) versus prednisolone acetate 1% (Prednefrin SF), for management of postoperative inflammation and pain, after cataract surgery.
This was a Phase III, multicenter, prospective, double-blind, clinical trial. Intent-to-treat population included 178 post-phacoemulsification patients that were assigned to receive either PRO-145, or prednisolone. One day after unilateral eye surgery, patients instilled a drop 4 times a day for 14 days (then tapering the dose downward for 14 days). The primary efficacy endpoints were anterior chamber (AC) cell grade and flare. Other parameters measured included: retinal central thickness (measured via OCT), conjunctival hyperemia, edema, pain and photophobia. Tolerability and safety were assessed through burning, itching, foreign body sensation, visual acuity (VA), intraocular pressure (IOP) and incidence of adverse events (AE).
A total of 171 subjects were randomized (1:1) and completed the study. Compared to day 1, there was a significant improvement in the AC cell count and flare in both groups by the final visit (80.2% vs 88.4%, p=1.000). Conjunctival hyperemia improved in a similar fashion (81.2% vs 79%, p=0.234) in both PRO-145 and prednisolone groups, without differences between them. This was also observed for edema (82.4% vs 82.5%, p=0.246), pain (15.3% vs 7%, p=0.497) and photophobia (16.4% vs 15.1%, p=0.246), respectively. There was no significant difference between treatments for any tolerability parameter studied. Finally, at the 4-week postoperative visit, there were no significant differences between treatments for VA, IOP and AE results (p-values; 0.095, 0.053 and 0.099, respectively).
The results of this study suggest that PRO-145 is as effective and safe as prednisolone acetate in treating postoperative inflammation and pain in patients undergoing phacoemulsification. The study was registered at ClinicalTrials.gov as NCT03693989.
本研究旨在比较0.05%双氟泼尼酯（PRO - 145）与1%醋酸泼尼松龙（Prednefrin SF）在白内障手术后控制炎症和疼痛方面的疗效和安全性。
这是一项III期、多中心、前瞻性、双盲临床试验。意向性治疗人群包括178例接受超声乳化白内障吸除术的患者，他们被分配接受PRO - 145或泼尼松龙治疗。单侧眼手术后一天，患者每天滴眼4次，持续14天（然后在接下来的14天逐渐减量）。主要疗效终点为前房细胞分级和闪光感。测量的其他参数包括：视网膜中央厚度（通过光学相干断层扫描测量）、结膜充血、水肿、疼痛和畏光。通过烧灼感、瘙痒感、异物感、视力（VA）、眼压（IOP）和不良事件（AE）发生率评估耐受性和安全性。
共有171名受试者随机分组（1:1）并完成了研究。与第1天相比，两组在末次随访时前房细胞计数和闪光感均有显著改善（80.2%对88.4%，p = 1.000）。PRO - 145组和泼尼松龙组结膜充血改善情况相似（81.2%对79%，p = 0.234），两组间无差异。水肿（82.4%对82.5%，p = 0.246）、疼痛（15.3%对7%，p = 0.497）和畏光（16.4%对15.1%，p = 0.246）情况也是如此。所研究的任何耐受性参数在治疗组间均无显著差异。最后，在术后4周随访时，治疗组在视力、眼压和不良事件结果方面无显著差异（p值分别为0.095、0.053和0.099）。
本研究结果表明，在治疗接受超声乳化白内障吸除术患者的术后炎症和疼痛方面，PRO - 145与醋酸泼尼松龙同样有效且安全。该研究已在ClinicalTrials.gov注册，注册号为NCT03693989。
