A prospective, open-label, multicentric, single-arm, post-marketing clinical study to evaluate effectiveness and safety of Cross-Linked Sodium Hyaluronate 24mg with Lidocaine 3mg Injection in subjects undergoing treatment for facial wrinkles and lip augmentation.

BACKGROUND: Hyaluronic acid (HA) fillers are quite commonly used since several years for soft tissue augmentation. AIM: The purpose of this study was to evaluate primarily the safety and secondarily the clinical effectiveness of Cross-Linked Sodium Hyaluronate 24 mg with Lidocaine 3 mg (Jeunesso 24L) injection, in subjects undergoing treatment for facial wrinkles and lip augmentation. METHOD: Patients between the age groups of 18 and 75 years, who were seeking soft tissue augmentation treatment on the face and with wrinkle severity score (WSS) ≥2 for bilateral Nasolabial Folds (NLF), were included in the study. The appropriate quantity of the filler was injected at the treatment site. Clinical efficacy assessments were conducted independently at 3 and 6 months after baseline. Clinical efficacy was assessed using Wrinkle Severity Rating Scale (WSRS) and a Global Aesthetic Improvement Scale (GAIS). RESULTS: The mean pain score was found to be 2.57 ± 2.06 immediately after injection which was reduced to 0.1 ± 0.675 at 15 min and this further subsided to "No Pain" in any of the participants at 60 min post the injection. WSRS mean score before treatment was 2.76, which were significantly reduced to 2.14, at 3 months. Majority of participants found an improvement in the marionette line severity. Also, significant improvements were seen in the perioral and lip areas. The Study filler was well-tolerated and no side effects were reported. CONCLUSION: The study indicates that this particular filler, HA+L, is useful for cosmetic improvements in the nasolabial folds and for enhancement of the lips.

Five Years' Outcomes of Trabeculectomy with Cross-linked Sodium Hyaluronate Gel Implantation for Chinese Glaucoma Patients.

BACKGROUND: Trabeculectomy is the most efficient surgical treatment. Prevention failure of bleb cicatrix would lead to unsatisfactory postoperative intraocular pressure (IOP) controlling and unsatisfactory success rate. The aim of this study was to evaluate the 5-year outcomes of trabeculectomy with a cross-linked sodium hyaluronate gel implantation for Chinese glaucoma patients. METHODS: This is a prospective, case-controlled study. Patients who were to be applied first-time trabeculectomy in the Department of Ophthalmology of Peking University Third Hospital between 2010 and 2012 were included in the study. Totally, 60 eyes were randomly assigned to the trabeculectomy group (TA group) or the trabeculectomy with cross-linked sodium hyaluronate gel implantation group (TH group). Follow-up was finished at 1 week, 1 month, 3 months, 1 year, 3 years, and 5 years after the operation. The statistical index of demographic data, IOP, bleb shape, and any complications or medications or surgical procedures were recorded and assessed by SPSS 19.0 software through independent t-test, one-way analysis of variance (ANOVA) and Pearson's Chi-square test, respectively. RESULTS: The baseline IOP was comparable between the two groups (t= -1.00, P= 0.32) while the postoperative IOP was significantly lower in the TH group at 1, 3 and 5 years' time points (P = 0.00, P= 0.01 and P = 0.01, respectively). According to the Indiana Bleb Appearance Grading Scale, the height and extent of bleb were better in the TH group at all follow-up time points (P < 0.05), however, the comparison of bleb vascularity showed no statistical difference (P > 0.05). TA group had a higher percentage of complications (13% vs. 3%) compared to TH group; however, there was no statistical difference in the comparison of each statistical item (P > 0.05, respectively). The complete success at 5 years was higher in the TH group than that in the TA group (78% vs. 54%, P = 0.03). CONCLUSION: Our results suggested that implantation of cross-linked sodium hyaluronate gel with trabeculectomy was more efficient and would improve the prognosis of glaucoma patients.

Five Years' Outcomes of Trabeculectomy with Cross-linked Sodium Hyaluronate Gel Implantation for Chinese Glaucoma Patients / 中华医学杂志(英文版)

<p><b>Background</b>Trabeculectomy is the most efficient surgical treatment. Prevention failure of bleb cicatrix would lead to unsatisfactory postoperative intraocular pressure (IOP) controlling and unsatisfactory success rate. The aim of this study was to evaluate the 5-year outcomes of trabeculectomy with a cross-linked sodium hyaluronate gel implantation for Chinese glaucoma patients.</p><p><b>Methods</b>This is a prospective, case-controlled study. Patients who were to be applied first-time trabeculectomy in the Department of Ophthalmology of Peking University Third Hospital between 2010 and 2012 were included in the study. Totally, 60 eyes were randomly assigned to the trabeculectomy group (TA group) or the trabeculectomy with cross-linked sodium hyaluronate gel implantation group (TH group). Follow-up was finished at 1 week, 1 month, 3 months, 1 year, 3 years, and 5 years after the operation. The statistical index of demographic data, IOP, bleb shape, and any complications or medications or surgical procedures were recorded and assessed by SPSS 19.0 software through independent t-test, one-way analysis of variance (ANOVA) and Pearson's Chi-square test, respectively.</p><p><b>Results</b>The baseline IOP was comparable between the two groups (t= -1.00, P= 0.32) while the postoperative IOP was significantly lower in the TH group at 1, 3 and 5 years' time points (P = 0.00, P= 0.01 and P = 0.01, respectively). According to the Indiana Bleb Appearance Grading Scale, the height and extent of bleb were better in the TH group at all follow-up time points (P < 0.05), however, the comparison of bleb vascularity showed no statistical difference (P > 0.05). TA group had a higher percentage of complications (13% vs. 3%) compared to TH group; however, there was no statistical difference in the comparison of each statistical item (P > 0.05, respectively). The complete success at 5 years was higher in the TH group than that in the TA group (78% vs. 54%, P = 0.03).</p><p><b>Conclusion</b>Our results suggested that implantation of cross-linked sodium hyaluronate gel with trabeculectomy was more efficient and would improve the prognosis of glaucoma patients.</p>

Preparation and Rheological Property of Cross-Linked Sodium Hyaluronate Gel / 中国药学杂志

OBJECTIVE: To prepare crossed-linked sodium hyaluronate (CHA) gel and study its rheological property. METHODS: CHA was prepared using 1, 4-butanediol diglycidyl ether (BDDE). The linear viscoelastic properties and creep recovery of hyalouronan(HA) and CHA were measured with a rheometer. The influencing factors of rheological properties were analyzed, such as concentration, proportion of cross-linker and temperature. RESULTS: Cross-linked sodium hyaluronate gel was prepared. The viscoelasticity was measured with a pair of 20 mm stainless steel plates at the frequency of 1 Hz and shear-strain of 1 Pa at (25±0.1)℃. As shown by the creep recovery test, CHA had a smaller strain and shorter time to recover to the minimum strain than HA, which showed typical linear viscoelastic and creep recovery properties. CONCLUSION: CHA is a non-Newtonian fluid, which is easy to administer and conforms completely to the requirements for viscoelastic supplementation materials for intra-articular injection. Compared with HA, CHA has more advantageous viscoelastic property and stability.

Comparative study of nanosized cross-linked sodium-, linear sodium- and zinc-hyaluronate as potential ocular mucoadhesive drug delivery systems.

Hyaluronic acid (HA) and its derivatives play important roles in many fields of therapy, such as arthritis treatment, plastic surgery, dermatology, otology, ophthalmology, etc. With a view to increase the beneficial properties of HA in ocular drug delivery, many types of chemical structural modifications have been performed. In the course of our research work, we characterized nanosized cross-linked - (CLNaHA), linear sodium hyaluronate (NaHA) and zinc-hyaluronate (ZnHA), as potential ocular drug delivery systems. The aim was to determine the influence of the structure on biocompatibility, mucoadhesion and drug release. The structure was characterized by means of rheology. The cytotoxicity of the samples was determined on rabbit corneal epithelial cells (RCE) by the MTT test. Mucoadhesion measurements were made by a rheological method in vitro and by tensile tests in vitro and ex vivo. The release of sodium diclofenac, a frequently used non-steroidal anti-inflammatory drug with low bioavailability, from the gels was determined with a vertical Franz diffusion cell. The results demonstrated that all three derivatives have adequate mucoadhesive properties and their rapid drug release profiles are beneficial in ocular therapy. Thanks to these properties, the bioavailability of the ophthalmic preparations can be increased, especially with the application of CLNaHA.

Determination of residual cross-linker vinyl sulfone in sodium hyaluronate injection / 中国生化药物杂志

Objective To establish a method to quantify the residual cross-linker vinyl sulfone and its hydration product 1 ,4-Thioxane-1 ,1-Dioxide.Methods The polysaccharide was precipitated by ethanol,however vinyl sulfone and its hydration product were soluble,and can be analyzed by direct injection.The analysis was carried on Agilent DB-wax capillary column (30m ×0.53 mm,1.0 μm).The flame ionization detector (FID)and flame photometric detector (FPD)were used to detect samples and the efficiency were compared. Results The linear range of vinyl sulfone and its hydration product were separately 0.5 ~20μg/mL and 2~100μg/mL detected by FID.The Limit of Quantity (LOQ)were 0.8μg/mL and 2.3μg/mL, respctively.The Limit of Detection (LOD)were 2.6μg/mLand 7.6μg/mL,respectively,and the average recoveries (n=9)of them were 104.3%and 92.4%,respectively.Conclusion FID could meet the needs of the test,and this method is simple and accurate with high sensitivity and good repeatability,which can be used for quality control of trace vinyl sulfone and its hydration products 1 ,4-Thioxane-1 ,1-Dioxide in cross-linked sodium hyaluronate injection.