PURPOSE: To compare the efficacy and safety of two carbomer 940 eye gels in the treatment of dry eyes: Lacrinorm (also called GelTears), a recently introduced eye gel, and Viscotears (also called Vidisic or Lacrigel), used as a reference gel. The main difference between the two gels is in the preservative, respectively benzalkonium chloride and cetrimide. METHODS: A double-masked, randomised, parallel-group study was conducted in 16 centres in four European countries. A total of 179 patients suffering from aqueous-deficient dry eye were enrolled, of whom 92 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. RESULTS: After 30 days of treatment, subjective symptoms (the combined scores of foreign body sensation, ocular dryness, burning or pain, and photophobia) had improved by 50% in the Lacrinorm group and by 45% in the reference gel group, and objective test results (break-up time, fluorescein test, Schirmer test, Lissamine Green test) by 35-36% in the Lacrinorm group and 25-45% in the reference group. The improvements were significant in both treatment groups (p < 0.001), with no significant differences 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 21 patients in the Lacrinorm group and 17 in the reference group, the most frequent being discomfort, blurred vision, hyperaemia, burning and itching. The frequency and descriptions of adverse events did not differ 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 treatment of dry eye.
RCT Entities:
PURPOSE: To compare the efficacy and safety of two carbomer 940 eye gels in the treatment of dry eyes: Lacrinorm (also called GelTears), a recently introduced eye gel, and Viscotears (also called Vidisic or Lacrigel), used as a reference gel. The main difference between the two gels is in the preservative, respectively benzalkonium chloride and cetrimide. METHODS: A double-masked, randomised, parallel-group study was conducted in 16 centres in four European countries. A total of 179 patients suffering from aqueous-deficient dry eye were enrolled, of whom 92 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. RESULTS: After 30 days of treatment, subjective symptoms (the combined scores of foreign body sensation, ocular dryness, burning or pain, and photophobia) had improved by 50% in the Lacrinorm group and by 45% in the reference gel group, and objective test results (break-up time, fluorescein test, Schirmer test, Lissamine Green test) by 35-36% in the Lacrinorm group and 25-45% in the reference group. The improvements were significant in both treatment groups (p < 0.001), with no significant differences 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 21 patients in the Lacrinorm group and 17 in the reference group, the most frequent being discomfort, blurred vision, hyperaemia, burning and itching. The frequency and descriptions of adverse events did not differ 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 treatment of dry eye.