A multicenter, randomized, partial double blind, active control, parallel clinical trial to evaluate the efficacy, safety and usability of cyclosporin ophthalmic nanoemulsion 0.05% compared with cyclosporin ophthalmic emulsion 0.05% and diquafosol ophthalmic solution 3%
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 227
研究概览
简要总结
Primary endpoints showed statistically significant improvements in all groups. Primary endpoints were -6.60 for the CN group, -5.28 for the CE group, and -6.63 for the DQ group (National Eye Institute scale from 0 to 33), verifying the non-inferiority of CN compared to CE (95% confidence interval, -0.15 to 2.80, ?>-2.88). In intergroup comparison between CN and CE groups, the CN group had significantly more decreased conjunctival staining score at week 12. Intergroup comparison between CN and DQ groups showed consistent statistically significant improvements in TBUT and Schirmer test in the CN group. In the DQ group, TBUT showed late statistically significant improvement at week 12 and Schirmer test showed relatively short-term statistically significant improvement at week 4. Conclusions: Cyclosporine nanoemulsion 0.05% was equivalently efficient compared to cyclosporine emulsion 0.05% and diquafosol sodium 3%. In addition, CN showed significant improvements in several parameters for treatment of dry eyes.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) =19 years of age
- •2) moderate to severe Dry eye syndrome (Corneal BFS score(NEI scale) = 4 and = 10 sec on TBUT)
- •3) volentary agreement with signed informed consent
排除标准
- •1. cyclosporine or diquafosol use in any form(systemic, topical) within 4 weeks
- •2. medical condition or history within 4 weeks to be treated with topical agents besides artifical tears(glaucoma, ocular allergy, ocular inflammation/infectious disease, etc)
- •3. new start or medication change within 4 weeks for systemic drugs with probable effect on dry eye codition
- •4. sjogren syndrome
- •5. plan to wear contact lens during the study period
- •6. current or history of ocular disorders possibly affecting the study results(ocular surgery, trauma, diseases)
- •1) entropion, blepharelosis, blepharoplegia
- •2) ocular surgery history within 4 weeks or plan during the study period like punctal plug, punctal closure etc
- •3) herpetics keratopathy, conjunctival scarring by cicatricial keratoconjunctivitis, pterygium, congenital lacrimal gland shortage, neurogenic keratitis, keratoconus, corneal transplantation
- •7. known hypersensitivity to study medications
- •8, pregnancy or lactation
- •9. investigator's judge of inappropiation