COMPARISON OF THE EFFICACY AND SAFETY OF 2 EYE GELS IN THE TREATMENT OF DRY EYES - LACRINORM AND VISCOTEARS

Purpose To compare the efficacy and safety of two carbomer 940 eye gel s in the treatment of dry eyes: Lacrinorm (also called GelTears), a re cently introduced eye gel, and Viscotears (also called Vidisic or Lacr igel), used as a reference gel. The main difference between the two ge ls is in the preservative, respectively benzalkonium chloride and cetr imide. Methods A double-masked, randomised, parallel-group study was c onducted in 16 centres in four European countries. A total of 179 pati ents suffering from aqueous-deficient dry eye were enrolled, of whom 9 2 were randomised to treatment with Lacrinorm and 87 to the reference gel. Gel was instilled four times a day for a period of 30 days. Resul ts After 30 days of treatment, subjective symptoms (the combined score s of foreign body sensation, ocular dryness, burning or pain, and phot ophobia) had improved by 50% in the Lacrinorm group and by 45% in the reference gel group, and objective test results (break-up time, fluore scein test, Schirmer test, Lissamine Green test) by 35-36% in the Lacr inorm group and 25-45% in the reference group. The improvements were s ignificant in both treatment groups (p < 0.001), with no significant d ifferences between the treatment groups. Subjective local tolerability upon instillation on day 30 was rated 'good' or 'very good' by 91% of patients in both treatment groups. Adverse events were reported for 2 1 patients in the Lacrinorm group and 17 in the reference group, the m ost frequent being discomfort, blurred vision, hyperaemia, burning and itching. The frequency and descriptions of adverse events did not dif fer significantly between the two treatment groups. No serious adverse events were reported. Conclusions Over the period of study, Lacrinorm eye gel was as effective and safe as Viscotears/Lacrigel in the treat ment of dry eye.