Tauber Eye Center, Kansas City, MO.
Eye Research Foundation, Newport Beach, CA.
Cornea. 2021 Sep 1;40(9):1132-1140. doi: 10.1097/ICO.0000000000002622.
NOV03 has a unique dual mode of action to address dry eye disease (DED) associated with meibomian gland dysfunction. SEECASE evaluated the efficacy, safety, and tolerability of NOV03 at 2 dosing regimens compared with a saline comparator in patients with DED.
SEECASE was a prospective, multicenter, randomized, double-masked, saline-controlled clinical study. A total of 336 DED patients [tear film breakup time ≤5 seconds, abnormal meibum secretion, total corneal fluorescein staining (tCFS) score of 4 ≤ X ≤ 11 (National Eye Institute scale), Schirmer of ≥5 mm] were randomized in a 2:2:1:1 manner to NOV03 4 times daily (QID), NOV03 twice daily (BID), saline BID, and saline QID, respectively. The primary efficacy endpoint was tCFS staining at 8 weeks for both regimens. Secondary endpoints included visual analog scales and the Ocular Surface Disease Index questionnaire for symptom assessment.
The study met its primary endpoint, change from baseline of tCFS over control, for both dosing regimens QID and BID (P < 0.001 and P = 0.009, respectively). NOV03 also showed pronounced improvement in various symptoms. For the Eye Dryness Score, changes from baseline were statistically significant compared with those of the control at week 8 [P < 0.001 (QID) and P = 0.002 (BID)]. Benefits on tCFS and symptoms started at 2 weeks after start of treatment and were maintained over the study duration. The effects were dosing schedule dependent. NOV03 was well tolerated with instillation site reactions below 3% in both treatment regimes.
The SEECASE study demonstrated that NOV03 improves signs and symptoms in patients with highly symptomatic evaporative dry eye disease.
NOV03 具有独特的双重作用机制，可治疗与睑板腺功能障碍相关的干眼症（DED）。SEECASE 评估了 NOV03 在 2 种给药方案与生理盐水对照相比，在 DED 患者中的疗效、安全性和耐受性。
SEECASE 是一项前瞻性、多中心、随机、双盲、生理盐水对照的临床研究。共有 336 例 DED 患者[泪膜破裂时间≤5 秒，异常睑板腺分泌物，总角膜荧光素染色（tCFS）评分 4≤X≤11（国家眼科研究所量表），Schirmer 试验≥5mm]以 2:2:1:1 的比例随机分为 NOV03 每日 4 次（QID）、NOV03 每日 2 次（BID）、生理盐水 BID 和生理盐水 QID 组。主要疗效终点为 2 种方案的 8 周 tCFS 染色。次要终点包括视觉模拟量表和眼表疾病指数问卷，用于评估症状。
该研究达到了主要终点，两种给药方案 QID 和 BID 的 tCFS 自基线的变化均优于对照组（P<0.001 和 P=0.009）。NOV03 还显著改善了各种症状。对于眼干燥评分，与对照组相比，第 8 周的变化具有统计学意义[P<0.001（QID）和 P=0.002（BID）]。治疗 2 周后开始出现 tCFS 和症状改善，并在研究期间持续存在。疗效与给药方案有关。NOV03 两种治疗方案的滴注部位反应均低于 3%，耐受性良好。
SEECASE 研究表明，NOV03 可改善症状明显的蒸发性干眼症患者的体征和症状。
