Condition: Glaucoma · Cataract · Ophthalmological Disorder · Sponsor: Universiti Kebangsaan Malaysia Medical Centre
Microneedle (MN) is a mimic of a hypodermic needle, composed of hundreds of micron-sized, out-of-plane protrusions, typically arranged in arrays on a patch that can be applied onto the skin. MN can be fabricated from a variety of materials, preferably biocompatible polymers. Maltose, a natural carbohydrate, is a safe and biocompatible product that can be fabricated into MNs that are biodegradable and soluble within several minutes. Besides, local anaesthetic agents such as lignocaine can be impregnated within the MN matrix, facilitating its transdermal delivery more efficiently which results in enhanced efficacy. So far, maltose MN efficacy in enhancing the transdermal drug delivery (TDD) of lignocaine and thus reducing the pain experienced by healthy patients requiring venepuncture prior to routine eye surgeries (phacoemulsification, trabeculectomy etc) has not been extensively studied. Hence, the objectives of this research are: 1) To evaluate the safety profile of lignocaine-embedded microneedle patch as a means of pain reduction in adult patients requiring routine vein-puncturing procedures; 2) To assess the pharmacokinetic (PK) parameters of lignocaine in the systemic circulation when the transdermal lignocaine delivery is enhanced through microneedle usage; 3) To compare the efficacy of lignocaine-embedded microneedle patch with standard 5% Eutectic Mixture of Local Anesthetics (EMLA) dermal patch for pain reduction during venepuncture procedure based on mean changes in…
This description comes directly from the study's public registry record.
MUHAMMAD IRFAN BIN ABDUL JALAL, MBChB BAO, PhD · +60172107299 · irfan.abduljalal@ukm.edu.my
CHENSHEN LAM, MD, D.OPHTH · +6017-6051693 · lamchenshen@ukm.edu.my
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| Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia (Ukm Medical Centre) | Kuala Lumpur, Kuala Lumpur, Malaysia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05694858