Purpose

To understand the safety of treating contact lens (CL) discomfort with a new artificial tear when it is directly applied to a CL-wearing eye.

Methods

This was a two-week, two-visit, double-masked study that randomized participants with CL discomfort to use Systane Complete (artificial tear), Sensitive Eyes (rewetting drop), or no treatment. Drops were applied before, twice during, and after CL use each day. Corneal staining served as the primary safety metric. Conjunctival staining, tear break-up time, Schirmer’s test, CL comfort (Contact Lens Dry Eye Questionnaire-8 [CLDEQ-8]), and dry eye symptoms (Standardized Patient Evaluation of Eye Dryness [SPEED]) were also evaluated.

Results

This study recruited 73 participants with a mean age of 30.3 ± 11.5 years; 18 % of the participants were male. There were no significant changes in ocular surface signs from baseline or between the artificial tear and rewetting drop groups after two weeks (p ≥ 0.05). Participants in the artificial tear and rewetting drop groups had significant improvements in CLDEQ-8 scores after two weeks of treatment compared with baseline (p < 0.0001), though scores for this test were not significantly different between these groups after two weeks (p = 0.94). CLDEQ-8 scores were significantly better in the artificial tear and rewetting drop groups compared with no treatment after two weeks (p < 0.0001).

Conclusions

Both drops were found to be safe for use with CLs while also significantly improving ocular symptoms compared to no treatment after two weeks of use.

中文翻译：

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systane complete治疗隐形眼镜不适的应用

目的

了解将新型人工泪液直接应用于佩戴 CL 的眼睛时治疗隐形眼镜 (CL) 不适的安全性。

方法

这是一项为期两周、两次访问、双盲的研究，将 CL 不适的参与者随机分配到使用 Systane Complete（人工泪液）、Sensitive Eyes（再润湿滴剂）或不治疗。每天在 CL 使用之前、期间和之后滴入滴剂。角膜染色作为主要的安全指标。还评估了结膜染色、泪液破裂时间、Schirmer 测试、CL 舒适度（隐形眼镜干眼问卷 8 [CLDEQ-8]）和干眼症状（眼睛干燥的标准化患者评估 [SPEED]）。

结果

该研究招募了 73 名平均年龄为 30.3 ± 11.5 岁的参与者；18% 的参与者是男性。两周后，眼表体征与基线或人工泪液和再润湿滴剂组之间没有显着变化（p ≥ 0.05）。与基线相比，人工泪液和再润湿滴剂组的参与者在治疗两周后的 CLDEQ-8 评分显着改善（p < 0.0001），尽管两周后这些组之间的测试分数没有显着差异（p = 0.94 ）。与两周后未处理相比，人工泪液和再润湿滴剂组的 CLDEQ-8 评分显着提高（p < 0.0001）。

结论

两种滴剂都被发现与 CL 一起使用是安全的，同时与使用两周后不进行治疗相比，还显着改善了眼部症状。