Clinical Study (II)

Efficacy  and safety in reducing signs and symptoms in patients suffering from dry-eye[1]

OBJECTIVE: The objective of this clinical study was to assess efficacy, safety and tolerability of LIPITEARTM (formerly LIPIMIX™) in reducing signs and symptoms in patients suffering from dry-eye syndrome.

METHODS: The experimental protocol design was a single-blind, randomized clinical study, carried out in parallel groups controlled vs. Hyaluronic acid 0,2% (HA) 50 patients (50 eyes).

TREATMENT: 1 drop 3 or more times daily for 90 consecutive days.

EFFICACY VARIABLES:

  • Symptoms: pain/burning sensation, blurred vision, foreign body sensation, photophobia, tear formation
  • Break Up Time (BUT)
  • Signs: conjunctival hyperemia, conjunctival edema, palpebral edema

RESULT: In terms of efficacy, LIPITEARTM was proved to be more effective than Hyaluronic acid 0.2%, in reducing signs and symptoms in patients suffering from dry eye. As for safety, tolerability was excellent for both treatments.

Graph: Efficacy and safety shown by the reduction of symptoms, the reduction of signs, cornea staining and a multivariate analysis

[1] Aragona P., Rolando M., Bonini S., Barozzi C., Falchetti R., De Gregorio F. Efficacy and safety of an ophthalmic microemulsion Lipimix in patients suffering from Dry Eye: single masked randomised clinical trial.  ISOPT 6th ,  Berlin, 2006 Medimonds S.r.l. ed. pg 81-86.