Aim: To compare the risk/benefit for C974P (a 0.25% fluid carbomer gel in a vial allowing dropwise instillation) versus a conventional carbomer gel.
Material and methods: During this multicenter, randomized, investigator-masked trial, patients with dry eye syndrome were treated with C974P or C940. Control visits were planned on day 7, day 28 (efficacy evaluation) and day 56 (tolerance evaluation). The main criterion was dry eye symptoms globally assessed by a visual analog scale (VAS). The non-inferiority limit for the between-group difference of VAS changes was 10 mm.
Results: In the population of 169 patients (87 patients for C974P, 82 for C940), C974P was at least as effective as C940 on symptoms (non-inferiority hypothesis confirmed). The mean VAS value fell by one third in the two groups. The objective signs improved identically in the two groups: corneal staining by fluorescein (p=0.96), rose Bengal score (p=0.73), and lacrimal break-up time (p=0.73). The dosage adaptation was slightly lower than three instillations per day (p=0.16). The adverse events were mild or moderate.
Conclusion: C974P galenic changes are able to reach the same level of efficacy on dry eye symptoms and ocular surface damages as the conventional tube carbomer gels.