Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Dr. Gerhard Mann chem.-pharm. Fabrik GmbH, Brunsbütteler Damm 165-173, 13581 Berlin, Germany
Viscotears Single Dose Unit is a preservative-free liquid gel containing carbomer. After local instillation it spreads rapidly over the conjunctiva and cornea and forms a lubricating film with prolonged contact time.
The retention times of Viscotears Liquid Gel (a similar product containing a preservative) and a conventional tear substitute based on polyvinylalcohol were studied in 30 healthy volunteers with fluorescein staining. The retention time of Viscotears Liquid Gel was approximately 16 minutes compared with approximately 2 minutes for the conventional artificial tears eye drops. Tear film stability was maintained for a period of up to 6 hours. Data of clinical studies on healthy volunteers, patients with dry eye and patients in intensive care or during operation suggest evidence that Viscotears Liquid Gel improves tear film stability and prolongs tear break-up time (BUT).
There are no controlled animal or human pharmacokinetic studies available. However, absorption or accumulation in eye tissues can presumably be excluded due to the high molecular weight of polyacrylic acid (4 mio D).
The results of the preclinical tests do not add anything of further significance to the prescriber.
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