Device Dossier
IDROFLOG- Lubricant, eye
Device Dossier for IDROFLOG- Lubricant, eye (Lubricant, eye, Class III, sponsor Mentholatum). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: Lubricant, eye
- Sponsor: Mentholatum
Intended purpose
IDROFLOG is an ophthalmic solution containing Sodium Hyaluronate which, thanks to its mucomimetic and pseudoplastic properties, is evenly distributed on the ocular surface forming a viscoelastic protective bandage. In this way, performing a mechanical action (“barrier effect”), IDROFLOG stabilizes the tear film and reduces the friction caused by eye movements and blinking; it protects the ocular surface of the eye, encouraging repair processes after discomfort of the cells of the corneal epithelium due to hyposecretion of the tear film. In fact, if the glands that secrete the tear film reduce – due to different factors – their normal activity, the corneal surface is then exposed more strongly to external factors. The latter, in time, cause a malfunctioning of the corneal epithelial cells with associated risk of the onset of troublesome inflammatory processes. Applying the IDROFLOG bandage protects the corneal surface from exposure to external factors and, thanks to ancillary action of the Hydrocortisone Sodium Phosphate (low-dose, low anti-inflammatory power and short-term action cortisone agent), helps to prevent the risk of any recurrences of inflammation. Finally, IDROFLOG, thanks to its special saline composition, restores and maintains at physiological levels the major ion concentrations, such as sodium, potassium and magnesium, essential for the health of the eye surface.
Functional description
IDROFLOG is a preservative-free ophthalmic solution containing sodium hyaluronate and low-dose hydrocortisone sodium phosphate. It forms a viscoelastic protective bandage on the ocular surface, stabilizes the tear film, reduces friction, and provides precautionary anti-inflammatory action for dry eye and ocular discomfort. Suitable for contact lens wearers. Use under specialist supervision