Stapleton Fiona, Hinds Mark, Tan Jacqueline, Jones Lyndon, Chalmers Robin, Bosworth Charles, Alster Yair
School of Optometry and Vision Science, UNSW Sydney, Sydney, Australia.
Ophthalmic Trials Australia, Brisbane, Australia.
Ocul Surf. 2024 Dec 28. doi: 10.1016/j.jtos.2024.12.009.
Contact lens discomfort (CLD) is a common problem for CL wearers, and patients with CLD often have changes in meibomian gland function and structure. In a Phase 2 trial AZR-MD-001 0.5% (AZR) ophthalmic ointment improved meibomian gland dysfunction (MGD) in non-lens wearers. The current study evaluated the efficacy and safety of AZR in participants with CLD and concomitant MGD.
Adults with CLD (Contact Lens Dry Eye Questionnaire-8 >12, range 0-37) and MGD (Meibomian Gland Secretion Score [MGS] ≤12, range 0-45) were randomized (1:1) to AZR:vehicle applied twice-weekly in a three-month multicenter, prospective, double-masked study. Endpoints included difference in change from baseline (CFB) in the number of Meibomian Glands Yielding Liquid Secretion (MGYLS), MGS, the ability to wear their lenses as long as desired, and safety.
At Month 3, AZR (n = 34) significantly increased the MGYLS and MGS versus vehicle (n = 33), with least squares mean difference (LSMD) CFB in MGYLS of 5.0 (SE = 0.47) for AZR and 1.6 (0.45) for vehicle, P < 0.0001; MGS of 13.8 (SE = 0.67) for AZR and 3.8 (SE = 0.68) for vehicle, P < 0.0001. Significantly more participants treated with AZR were able to wear lenses as long as desired (43% vs. 6%, P = 0.0023). The most common treatment-emergent adverse event (TEAE) was eye irritation (61.8% AZR; 0% vehicle). All TEAEs related to treatment were mild/moderate, transient, and did not result in discontinuation.
AZR-MD-001 0.5% significantly improved MGD signs and hours of comfortable CL wear, demonstrating good efficacy, safety, and tolerability in those with CLD.
隐形眼镜不适（CLD）是隐形眼镜佩戴者的常见问题，患有CLD的患者睑板腺功能和结构常发生改变。在一项2期试验中，0.5%的AZR-MD-001（AZR）眼膏改善了非隐形眼镜佩戴者的睑板腺功能障碍（MGD）。本研究评估了AZR在患有CLD并伴有MGD的参与者中的疗效和安全性。
患有CLD（隐形眼镜干眼问卷-8评分>12，范围0-37）和MGD（睑板腺分泌评分[MGS]≤12，范围0-45）的成年人被随机（1:1）分为AZR组和赋形剂组，在一项为期三个月的多中心、前瞻性、双盲研究中每周两次应用。终点指标包括产生液体分泌物的睑板腺数量（MGYLS）、MGS从基线的变化差异（CFB）、按意愿佩戴隐形眼镜的时长以及安全性。
在第3个月时，与赋形剂组（n = 33）相比，AZR组（n = 34）的MGYLS和MGS显著增加，AZR组MGYLS的最小二乘均值差异（LSMD）CFB为5.0（标准误=0.47），赋形剂组为1.6（0.45），P < 0.0001；AZR组MGS为13.8（标准误=0.67），赋形剂组为3.8（标准误=0.68），P < 0.0001。接受AZR治疗的参与者中，能够按意愿佩戴隐形眼镜的人数显著更多（43%对6%，P = 0.0023）。最常见的治疗中出现的不良事件（TEAE）是眼部刺激（AZR组为61.8%；赋形剂组为0%）。所有与治疗相关的TEAE均为轻度/中度、短暂性，且未导致停药。
0.5%的AZR-MD-001显著改善了MGD体征和舒适佩戴隐形眼镜的时长，在患有CLD的患者中显示出良好的疗效、安全性和耐受性。
