MATERIAL AND METHODS: Patients with Spastic CP with Gross Motor Function Classification System (GMFCS) I-III that underwent lower limb surgical intervention in our centre from 2008-2018 were retrospectively reviewed for The Spinal Alignment and Range of Motion Measure ROM subscale (SAROMM) scores and Functional Mobility Scale (FMS) 18 months after surgery. Changes in SAROMM, FMS scores and minimal clinically important difference (MCID) were determined.
RESULTS: 19 patients were included in the study with mean age of 12.58. All patients underwent muscle tendon procedures. Box plot analysis of SAROMM showed reduction of median scores at 6(26.3%) and 12(47.4%) months which plateaus at 18 months post-surgery. Repeated measure ANOVA analysis showed there was a statistically significant effect of time on SAROMM scores (p <0.001) with MCID of 13.4. Improvement of FMS scores was the most at 50m with 13 children (p < 0.05), one at 5m and five at 500m. None reported worsening of FMS scores at 18 months. There were no changes of GMFCS levels by the end of 18 months.
CONCLUSION: Surgeries performed on GMFCS I-III patients with the aim of gait improvement translates into improved mobility with results comparable to other countries.
Materials and methods: In vitro irritation test was conducted on Latanost® (LTN) and Latacom® (LTC) and their corresponding innovators, Xalatan® (XLT) and Xalacom® (XLC), respectively, by using RhCE. According to the OECD guidelines No. 492 on the testing of chemicals, the ophthalmic formulations were assessed via topical exposure of the formulations on in vitro RhCE tissue. Cell viability was measured by MTT assay.
Results: The mean cell viability percentage of LTN and XLT was 70.5 and 75.7%, respectively, whereas, for LTC and XLC, the percentage viability was 95.3 and 85.7%, respectively. The two new generic formulations (LTN and LTC) did not reduce the cell viability of the RhCE tissue to ≤60%. Thus, both can be considered as nonirritant.
Conclusion: Both newly developed generics are nonocular irritants.
Clinical significance: This study informs the safety assessment of new generic antiglaucoma ophthalmic solutions applicable for long-term glaucoma treatment. The formulations aim to keep eye irritation to a minimum level.
How to cite this article: Ng JSC, Tan YX, Alwi NAA, et al. In Vitro Toxicity Evaluation of New Generic Latanost® and Latacom® as an Ophthalmic Formulation. J Curr Glaucoma Pract 2021;15(3):139-143.