Stapleton Fiona, Jia Tianni, DePuy Venita, Bosworth Charles, Gleeson Marc, Tan Jacqueline
School of Optometry and Vision Science, UNSW Sydney, NSW, Australia.
School of Optometry and Vision Science, UNSW Sydney, NSW, Australia.
Ocul Surf. 2025 Apr;36:190-197. doi: 10.1016/j.jtos.2025.01.015. Epub 2025 Jan 31.
To explore effects of topical 1 % selenium sulfide on signs and symptoms in symptomatic contact lens-wearers, in an exploratory 4-month prospective placebo-controlled double-masked randomised trial.
Symptomatic wearers (Contact Lens Dry Eye Questionnaire-8 [CLDEQ-8] score>12) with meibomian gland dysfunction (meibomian gland score (MGS)≤12), were enrolled and received either active (AZR-MD-001-containing 1 % selenium sulfide), or vehicle ointment, to the lower eyelid margin twice-weekly. MGS, meibomian glands-yielding liquid secretion (MGYLS), lipid layer thickness, tear meniscus height, tear break-up time, tear evaporation rate, lid wiper epitheliopathy, CLDEQ-8 and comfortable wear time (CWT) were measured at baseline and to 4-months. Differences between active and placebo were compared to baseline.
Fourteen participants (5M:9 F, 30.8 ± 13.8 years) completed the study. In the active group, change in MGS from baseline improved by 1-month (mean difference 7.9 ± 8.0, p = 0.03), to 4-months (16.0 ± 11.3, p < 0.01). MGYLS improved from baseline by 1.5-months (4.0 ± 3.3) to 4-months (4.1 ± 4.3, p < 0.01). In the vehicle, change in MGS (12.1 ± 10.7) and MGYLS (3.9 ± 3.2) were improved at 4-months only (p < 0.01). CLDEQ-8 score improved at 1-month and 4-months compared to baseline (-4.4 ± 3.2, -5.1 ± 4.7, p ≤ 0.02) in the active and at 4-months only in the vehicle group (-4.4 ± 6.4, p = 0.02). In the active group, CLDEQ-8 visual function scores improved at 1- and 4-months (p ≤ 0.02) and CWT at 4-months (median 7 vs.10 h, p = 0.025). Other signs were unchanged.
This exploratory study indicates that twice-weekly use of AZR-MD-001 ointment can rapidly improve gland patency and secretion in symptomatic contact lens-wearers. AZR-MD-001 reduced changeable/blurry vision and prolonged CWT, suggesting relevant future endpoints.
在一项为期4个月的探索性前瞻性安慰剂对照双盲随机试验中，探讨局部使用1%硫化硒对有症状的隐形眼镜佩戴者体征和症状的影响。
招募患有睑板腺功能障碍（睑板腺评分（MGS）≤12）的有症状佩戴者（隐形眼镜干眼问卷-8[CLDEQ-8]评分>12），并每周两次在下眼睑边缘涂抹活性药物（含1%硫化硒的AZR-MD-001）或赋形剂软膏。在基线和4个月时测量MGS、睑板腺产生液体分泌物（MGYLS）、脂质层厚度、泪液弯月面高度、泪膜破裂时间、泪液蒸发率、睑缘上皮病变、CLDEQ-8和舒适佩戴时间（CWT）。将活性药物组和安慰剂组与基线进行差异比较。
14名参与者（5名男性：9名女性，30.8±13.8岁）完成了研究。在活性药物组中，MGS从基线开始的变化在1个月时有所改善（平均差异7.9±8.0，p = 0.03），到4个月时（16.0±11.3，p < 0.01）。MGYLS从基线开始在1.5个月时有所改善（4.0±3.3），到4个月时（4.1±4.3，p < 0.01）。在赋形剂组中，MGS（12.1±10.7）和MGYLS（3.9±3.2）的变化仅在4个月时有所改善（p < 0.01）。与基线相比，活性药物组的CLDEQ-8评分在1个月和4个月时有所改善（-4.4±3.2，-5.1±4.7，p≤0.02），而赋形剂组仅在4个月时有所改善（-4.4±6.4，p = 0.02）。在活性药物组中，CLDEQ-8视觉功能评分在1个月和4个月时有所改善（p≤0.02），CWT在4个月时有所改善（中位数7小时对10小时，p = 0.025）。其他体征未改变。
这项探索性研究表明，每周两次使用AZR-MD-001软膏可迅速改善有症状的隐形眼镜佩戴者的腺体通畅性和分泌物。AZR-MD-001减少了视力变化/模糊，并延长了CWT，提示了相关的未来终点。
