Clinical Study (II)
Efficacy and safety in reducing signs and symptoms in patients suffering from dry-eye
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.
- 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.
 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.