Clinical Study (I)

Effect on the re-epithelization process in patients who underwent PRK[1]

OBJECTIVE: The objective of this clinical study was to demonstrate that in patients subjected to Photorefractive Keratectomy (PRK) surgery, the treatment with LIPITEARTM (formerly LIPIMIXTM) helps and accelerates the epithelium repairing processes (so called re-epithelization), thus improves both objective and subjective symptoms.

METHODS: The experimental design was a single-blind, randomized clinical study, carried out in parallel groups controlled vs. Hyaluronic acid 0,2%. 20 patients (40 eyes).

TREATMENT: 1 drop LIPITEARTM 4 times daily for 5 consecutive days, in addition to the standard antibiotic therapy. Same regimen for Hyaluronic acid in the contralateral eye.

EFFICACY VARIABLES:

  • Size of corneal erosion assessed by fluorescein vital staining
  • Erosion healing time
  • Symptoms: pain/burning sensation, blurred vision, feeling of foreign body, photophobia, lacrimation
  • Signs: conjunctival hyperemia, conjunctival edema, palpebral edema

RESULT: LIPITEARTM is more effective in supporting the re-epithelization process than Hyaluronic acid 0,2% by reducing signs and symptoms in patients who underwent PRK

Graph: Visual comparison of the results of the clinical study
* Multivariate analysis (Hotelling T2 test P=0.0959). AUC-related difference (Delta) in severity of symptoms between the treatments, expressed in standardized units during the 10-day observation period.
[1] Caporossi A., Rolando M., Barozzi C., Falchetti R., De Gregorio F. Effetc of an ophthalmic phospholipid-based on the re-epithelization process in patients who underwent to photorephractive keratectomy (PRK). Preliminary results. ISOPT  6th , Berlin, 2006 Medimonds S.r.l. ed. pg 97-102.