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C. Barozzi, F. De Gregorio, R. Falchetti, M. Rolando; Effects of a Phospholipid–Based Microemulsion (TBX–024) on Re–Epithelization Processes in Patients Suffering From Non Infectious Corneal Erosions: A Randomised Single Blind Pilot Study . Invest. Ophthalmol. Vis. Sci. 2005;46(13):2154.
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Purpose: The primary objective of this pilot study was to evaluate the effect of a phospholipid–based microemulsion named TBX–024 on both the extent of the erosion and the recovery time. The secondary objective of the study was to evaluate the effect of TBX–024 on either objective or subjective symptoms and on ocular and systemic tolerance Methods: Study design: randomised single blind clinical trial. Thirty patients suffering from non infectious corneal erosion were included in the study: 15 were treated with TBX–024 and 15 with 0.2% Sodium Hyaluronate (HA). Each patient instilled one drop of either TBX–024 or HA four times a day for five days. The following criteria for evaluation were used: Primary efficacy variable: measure of the size of lesion by fluorescein staining; complete recovery time (in hours). Secondary efficacy variable: Visual Analogic Scales (VAS) for subjective (pain, lachrymation, photophobia, foreign body sensation) and objective symptoms (conjunctival hyperemia, chemosis, oedema). Tolerability: global local tolerance assessment by the investigator on a VAS and global local tolerance assessment by the patient on a VAS; systemic safety variables; evaluation of adverse events. Results: Efficacy: The results of the study demonstrated that: 1) the patients treated with TBX–024 had a faster recovery time when compared with HA–treated patients; 2) the patients treated with TBX–024 had faster reduction of the severity of both objective and subjective symptomatology; 3) Both study products were judged efficacious by both investigator and patients. Tollerability and safety: Both local and systemic tolerance appeared to be very good with both study products. Conclusions: The results of this pilot study showed a "trend" of a better efficacy of TBX–024 vs HA in accelerating the recovery time and in reducing the severity of symptomatology, although not yet statistically significant. Further studies to demonstrate the clinical efficacy of TBX024 in wound healing processes are on going.
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