A randomized, multicenter clinical study to evaluate the efficacy and safety of sodium Hyaluronate according to multi-concentration in dry eye syndrome.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
Among 193 patients randomized, 176 patients were included for efficacy evaluation excluding 17 patients(consent withdrawal 7, follow-up loss 5, contradiced medication 4, pregnance 1). 176 patients were allocated randomly to receive 1 of the 4 treatments: 43 patients entered the 0.1% SH group, 41 patients entered the 0.15% SH group, 47 patients entered the 0.3% SH group, and 45 patients entered the 0.05% CS group. Of the total 176 participants, 147 were female (83.52%), and the mean age +-standard deviation (SD) was 45.06 +- 14.83 years. In the primary analysis, the mean change from baseline in FCS scores verified noninferiority of 0.1% and 0.15%SH to 0.05%CS and also indicated significant improvement of all groups (P< 0.05). Values for TBUT, LGCS scores, and OSDI scores showed significant improvements in all groups (P < 0.05), although no significant intergroup differencewas shown.However, Schirmer test scores in the 0.15%SHgroup showed a significant tendency for better improvement at week 12 compared with the other groups (P < 0.05). No serious adverse events were observed. In conclusion, this is the first study to evaluate the efficacy and safety of the 0.1% SH, 0.15% SH, and 0.3% SH compared with 0.05% CS in patients with dry eye. Our study showed that a 12-week, 4–6 times daily treatment with 0.1% SH, 0.15% SH, and 0.3% SH was as effective as 0.05% CS in improving the objective signs and subjective symptoms of dry eye. These results suggest that it may lead to improved treatment of corneal and conjunctival epithelial damage and improvement in symptoms in patients with dry eye. Such efficacy, in addition to the well-tolerated profile of 0.1% SH, 0.15% SH, and 0.3% SH, makes them potentially useful treatment options for dry eye in clinical practice.
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) Dry eye symdrome lasting at least 3 months
- •3) = 10mm in Schirmer's I test or = 5sec on BUT
- •4) NEI scale = 4
- •5) negative on pregnancy test if of childbearing potential
- •6) Menopause or agreed to use a reliable from of Contaception if of childbearing potential
- •7) volentary agreement with signed informed consent
排除标准
- •1) Current or histroy of systemic or ocular disorders possibly affecting the study results(ocular surgery, traum, or diseases)
- •(1) abnormal eyelid function: disorders of the eyelids or eyelashes
- •(2) ocular allergy history within 1 month or under treatment (topical ocular mast cell stabilizers, antihistamine etc.)
- •(3) herpetic keratopathy, conjunctival scarring by cicatricial keratoconjuntivitis(alkali damage, Stevens-Johnson Syndrome, cicatricial pemphigoid), pterygium, congenital lacrimal gland shortage, neurogenic keratitis, keratoconus, corneal transplantation
- •2) under or recent history of dry eye syndrome medications(topical or systemic) besides artificial tears(including diquafosol)
- •3) use of artificial tears(including diquafosol) within 1 week
- •4) Intraocular pressure(IOP) > 25mmHg
- •5) hypersensitivity to investigational drugs
- •6) surgery of punctual plug or lacrimal punctual occlusion within 4 weeks
- •7) ocular surgery within 8 weeks
- •8) pregnancy or breast-feeding or under childbearing plan
- •9) history of malignant tumor (those under treatment or history of anti-cancer therapy within 6 months)
- •10) under systemic steroids or immunosuppressants
- •11) renal dysfunction ( = 2 times of upper limit of normal serum creatinine)
- •12) hepatic dysfunction (= 2 times of upper limit of normal ALT or AST)
- •13) history of drug abuse including alcohol
- •14) participants in other clinical trial within the last month
- •15) investigator's judge of inappropiation