Gallois-Bernos Annabelle, Zhong Lichun, Bai Mingqi, Blackie Caroline A
Johnson & Johnson Vision Care, Inc., Jacksonville, FL, USA.
Labcorp, Bedford, MA, USA.
Transl Vis Sci Technol. 2025 Jan 2;14(1):28. doi: 10.1167/tvst.14.1.28.
The objective of this three-phase study was to develop a model of mild to moderate evaporative dry eye to be used to evaluate tear film stability endpoints during product development.
Rabbits were sedated prior to ophthalmic cautery of meibomian gland orifices. The orifices of eyelid meibomian glands were half-cauterized (to yield obstruction of every other meibomian gland orifices), fully cauterized (to yield obstruction of all meibomian gland orifices), or untreated. The primary outcome measures were model repeatability, tear film break-up time (TBUT), non-invasive tear break-up time (NIBUT), and model confirmation with daily artificial tears. Other examinations included Draize score, tear production, fluorescein staining, eschar, and histopathology.
Cauterization was well tolerated in all phases. In phase I, TBUT was significantly decreased compared to baseline on days 14, 21, 28, and 35 in fully cauterized meibomian gland orifices but not in half-cauterized meibomian gland orifices. In phase II, both NIBUT and TBUT were similarly and significantly reduced in the fully cauterized meibomian gland orifices compared to the control eyes on days 7, 9, 14, and 28. In the confirmation phase, the administration of eye drops significantly improved NIBUT over the course of the study.
A rabbit model of dry eye was successfully and safely created through the obstruction of meibomian gland orifices by cautery, which yielded a significant reduction in tear film stability. A quantifiable benefit of artificial tears relative to untreated control was demonstrated within the model.
When the model is deployed, the utility and efficacy of therapeutic formulations can be evaluated.
这项三阶段研究的目的是建立一个轻至中度蒸发型干眼模型，用于在产品研发过程中评估泪膜稳定性终点指标。
在对睑板腺开口进行眼科烧灼术前，先对兔子进行镇静。眼睑睑板腺开口进行半烧灼（使每隔一个睑板腺开口阻塞）、全烧灼（使所有睑板腺开口阻塞）或不进行处理。主要观察指标包括模型的可重复性、泪膜破裂时间（TBUT）、非侵入性泪膜破裂时间（NIBUT）以及每日使用人工泪液对模型的验证。其他检查包括德雷兹评分、泪液分泌、荧光素染色、焦痂和组织病理学检查。
在所有阶段，烧灼术的耐受性良好。在第一阶段，全烧灼睑板腺开口的兔子在第14、21、28和35天时，TBUT与基线相比显著降低，但半烧灼睑板腺开口的兔子未出现这种情况。在第二阶段，与对照眼相比，全烧灼睑板腺开口的兔子在第7、9、14和28天时，NIBUT和TBUT均同样显著降低。在验证阶段，在研究过程中，滴眼剂的使用显著改善了NIBUT。
通过烧灼阻塞睑板腺开口成功且安全地创建了一种干眼兔模型，该模型使泪膜稳定性显著降低。在该模型中证明了人工泪液相对于未处理对照的可量化益处。
当应用该模型时，可以评估治疗制剂的效用和疗效。
