Safety and immunogenicity of subcutaneous or intramuscular administration of a monovalent inactivated vaccine against Leptospira interrogans serogroup Icterohaemorrhagiae in healthy volunteers.

The safety and immunogenicity of a monovalent inactivated vaccine against Leptospira interrogans serogroup Icterohaemorrhagiae was evaluated in 84 volunteers according to the route of administration, i.e., subcutaneous (SC) or intramuscular (IM), in a double-blind randomised trial. The volunteers were randomised into four groups: SC vaccine; IM vaccine; SC placebo; and IM placebo. Primary vaccination comprised two injections on day 0 and day 14, with a booster after 6 months. A second booster was given 30 months after primary vaccination. Local reactions within 1 h of injections were rare, with no difference between vaccine groups. Local reactions within 3 h were more frequent after the second, third and fourth SC injections than after IM injections. Systemic reactions never occurred within 1 h of vaccination and were rare within 3 days; the rates were comparable for the different vaccine groups. Evolution of the antibody responses, as assessed by microscopic agglutination tests and specific IgG and IgM ELISAs, were similar for both injection routes. IgG seroconversion rates after the first booster were 97% (95% CI 80-100%) for the SC vaccine group, and 96% (95% CI 80-100%) for the IM vaccine group, and both reached 100% for IgG after the second booster. The safety and immunogenicity of the anti-leptospiral vaccine were both good. Monitoring of antibody levels established that a booster dose triggered a strong antibody response in fully vaccinated subjects at 30 months after primary vaccination.

[Efficacy and safety of a fluid carbomer gel versus a conventional carbomer gel in dry eye treatment]. / Efficacité et tolérance d'un gel de carbomère fluide versus un gel de carbomère classique lors du traitement du syndrome sec.

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.

[Ocular tolerance of a new formulation of nonpreserved diclofenac]. / Intérêt d'une nouvelle formulation de diclofénac sans conservateur pour la surface oculaire.

AIM: To compare the ocular tolerance of nonpreserved diclofenac versus thiomersal-preserved diclofenac in healthy volunteers. MATERIALS AND METHODS: Forty healthy volunteers instilled Dicloabak in the randomised eye and thiomersal-preserved diclofenac in the other eye, according to a strictly identical dosing regimen, for 28 days. Each volunteer thus served as his or her own control. The dose regimen was five drops/day for 7 days followed by three drops/day for 20 days. Ocular tolerance was assessed by the discomfort upon instillation (measured on a visual analogue scale [VAS]), subjective ocular symptoms following instillation (irritation/burning/stinging, eye dryness and foreign body sensation) and finally by an objective examination of the ocular surface. These criteria were evaluated on days 0, 14, 21 and 28. RESULTS: The subjective ocular symptoms following instillation were significantly lower in the nonpreserved group at Day 7 and nearly significantly lower until the end of the study. The biomicroscopy exam confirmed that there was better tolerance without thiomersal. There was less follicular-papillary conjunctivitis and a significantly better lissamine green score in the Dicloabak group. CONCLUSION: The results of this study demonstrate that the nonpreserved formulation of diclofenac is better tolerated by the ocular surface and thus constitutes a therapeutic benefit.

Comparison of preservative-free ketotifen fumarate and preserved olopatadine hydrochloride eye drops in the treatment of moderate to severe seasonal allergic conjunctivitis.

PURPOSE: To compare preservative-free ketotifen 0.025% ophthalmic solution to olopatadine 0.1% ophthalmic solution in with the treatment of seasonal allergic conjunctivitis (SAC) in clinical practice. METHODS: This was a comparative, randomised, investigator-masked, pilot clinical study in adult patients with documented history of SAC and presenting with moderate to severe itching and conjunctival hyperemia. Eligible patients initiated either ketotifen or olopatadine treatment at a dose of one drop twice daily for 28days. The resolution of ocular signs and symptoms was assessed on day 7 and day 28. Itching was also assessed within 15minutes following the first instillation (day 0). Conjunctival impression cytology was performed at each visit to assess the evolution of ICAM-1 expression (day 0, 7 and 28). RESULTS: Seventy-five patients were randomised (ketotifen: 38 patients; olopatadine: 37 patients). At day 28, the composite score for primary criteria (itching, tearing, and conjunctival hyperemia) improved from 6.8±1.2 to 0.9±1.0 in the Ketotifen group, without statistically significant difference between treatment groups (P=0.67). There was no relevant difference between treatment groups in other efficacy parameters, except a trend for a more rapid resolution of conjunctival hyperemia in the Ketotifen group. Both drugs were well tolerated, with a trend for a better tolerability reported by patients on ketotifen compared to those on olopatadine at day 7 (P=0.054). CONCLUSIONS: A rapid and comparable improvement in SAC was achieved after 28days of treatment with both preservative-free ketotifen and preserved olopatadine ophthalmic solutions, with a slightly better ocular tolerance with unpreserved ketotifen 0.025% eye drops.