Salam Ayesha A, Sen Seema, Lomi Neiwete, Gupta Noopur, Vanathi Murugesan, Tandon Radhika
Department of Ophthalmology, Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.
Department of Pathology, Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.
Indian J Ophthalmol. 2025 Apr 1;73(4):577-581. doi: 10.4103/IJO.IJO_1850_24. Epub 2025 Mar 27.
To compare the clinical response of patients with moderate-to-severe dry eye disease to treatment with 0.05% cyclosporine eye drops as an aqueous solution or oil emulsion.
Prospective randomized clinical trial.
An institutional study where 88 patients with moderate-to-severe dry eye was enrolled after written informed consent and randomized to receive either aqueous solution (Group 1) or oil emulsion (Group 2) 0.05% cyclosporine eye drops in twice daily dosing in addition to lubricant eyedrop 0.5% carboxymethylcellulose six times/day in both eyes. Comprehensive eye examination and baseline parameters were recorded, and clinical assessment was repeated at 4, 8, and 12 weeks. Parameters evaluated included ocular surface disease index score (OSDI), Schirmer test, tear break-up time (TBUT), corneal fluorescein staining - National Eye Institute (NEI) scoring, lipid layer thickness (LLT), tear meniscus height (TMH), non-invasive tear break-up time (NIBUT), percentage loss of meibomian glands, and impression cytology (number of goblet cells/hpf).
The mean age was 39 ± 15.6 years and 42 ± 17.7 years, and the M:F ratio was 26:19 and 20:24 in Groups 1 and 2, respectively. Both the groups showed comparable values at baseline. After treatment, there was statistically significant improvement over baseline values in both groups at 4, 8, and 12 weeks. At 12 weeks for the following parameters, there was no significant difference between the groups, though there was an improvement over baseline in Groups 1 and 2, respectively, as follows: OSDI score - 30.89, 33.28 (P < 0.001), Schirmer test - 5 mm, 4 mm (P < 0.001), TBUT - 2.65 sec, 3.07 sec (P < 0.001), NEI score - 2, 2 (P < 0.001) and the number of goblet cells/hpf - 1.5,9 (P = 0016, P = 0.001). A higher number of patients, by a value of 9, in Group 2 showed an increase in the number of goblet cells/hpf. The NIBUT value showed statistically significant improvement in Group 2 compared to Group 1 (P = 0.011). Group 2 also showed statistically significant improvement in TMH by the 8th week (P = 0.015) and in LLT by the 12th week (P < 0.001). Group 1 comparatively showed earlier improvement in LLT by the 4th week (P = 0.027).
Both aqueous solution and oil emulsion 0.05% cyclosporine formulations appear to be equally effective in the management of dry eye disease with a comparatively better response with oil emulsion formulations.
比较中度至重度干眼症患者使用0.05%环孢素滴眼液水溶液或油乳剂治疗的临床反应。
前瞻性随机临床试验。
一项机构研究，88例中度至重度干眼症患者在签署书面知情同意书后入组，随机分为两组，分别接受0.05%环孢素滴眼液水溶液（第1组）或油乳剂（第2组）治疗，每日滴眼两次，同时双眼每日6次使用0.5%羧甲基纤维素润滑滴眼液。记录全面的眼部检查和基线参数，并在第4、8和12周重复进行临床评估。评估的参数包括眼表疾病指数评分（OSDI）、泪液分泌试验、泪膜破裂时间（TBUT）、角膜荧光素染色 - 美国国立眼科研究所（NEI）评分、脂质层厚度（LLT）、泪河高度（TMH）、非侵入性泪膜破裂时间（NIBUT）、睑板腺缺失百分比和印迹细胞学检查（杯状细胞数量/高倍视野）。
第1组和第2组的平均年龄分别为39±15.6岁和42±17.7岁，男女比例分别为26:19和20:24。两组在基线时显示出可比的值。治疗后，两组在第4、8和12周时与基线值相比均有统计学上的显著改善。在第12周时，以下参数在两组之间无显著差异，尽管第1组和第2组与基线相比均有改善，具体如下：OSDI评分 - 30.89、33.28（P<0.001），泪液分泌试验 - 5mm、4mm（P<0.001），TBUT - 2.65秒、3.07秒（P<0.001），NEI评分 - 2、2（P<0.001）以及杯状细胞数量/高倍视野 - 1.5、9（P = 0.016，P = 0.001）。第2组中杯状细胞数量/高倍视野增加的患者数量比第1组多9例。与第1组相比，第2组的NIBUT值有统计学上的显著改善（P = 0.011）。第2组在第8周时TMH也有统计学上的显著改善（P = 0.015），在第12周时LLT有统计学上的显著改善（P<0.001）。第1组在第4周时LLT相对较早出现改善（P = 0.027）。
0.05%环孢素滴眼液的水溶液和油乳剂在干眼症治疗中似乎同样有效，油乳剂配方的反应相对更好。
