netilmicin and Inflammation

To demonstrate efficacy and safety of an ophthalmic hydrogel formulation of netilmicin/dexamethasone, containing xanthan gum twice a day (b.i.d.) versus netilmicin/dexamethasone eye drops four times a day (q.i.d) to treat inflammation and prevention of infection after cataract surgery.. Patients undergoing phacoemulsification with intraocular lens implantation (IOL) were randomised in two groups: group 1, twice daily (b.i.d.) dexamethasone 0.1%/netilmicin 0.3% (Netildex) ophthalmic gel; group 2, four times daily (q.i.d.) dexamethasone 0.1%/netilmicin 0.3% (Netildex) eye drops. Both treatments were administered for 14 days after surgery. Patients were evaluated before surgery, on the day of surgery and at 1, 7, 15 and 60 postoperative days. The primary efficacy endpoint was evaluation of cellularity and flare in the anterior chamber through slit-lamp biomicroscopy 7 days after surgery. Secondary endpoints included: presence of signs/symptoms of postoperative ocular inflammation and incidence of infection.. One hundred seventy-three patients were randomised and 168 were evaluable. Flare and cellularity were resolved at day 7 in 92.5% of patients and almost completely by day 15. In both intent to treat (ITT) and per-protocol (PP) populations, the efficacy analysis demonstrated that the gel formulation administered twice a day was non-inferior to the eye drops administered four times a day. For ITT analysis, the lower limit of the 97.5% confidence interval (- 0.0535) was greater than the non-inferiority limit of -0.10. For the PP analysis, the lower limit of the 97.5% confidence interval (- 0.0526) was greater than the non-inferiority limit of - 0.10. The patient's global tolerability and reported symptoms were similar between treatment groups. No microbial load and no safety events were observed.. Efficacy of the gel reduced posology (twice a day) is not inferior to four times a day eye drops. Both treatments were well tolerated and efficacious. The new reduced posology hydrogel formulation may improve patient compliance and quality of life.. Eudract: 2016-0021138-63; ClinicalTrial.gov: NCT029738880.

Topics: Cataract; Dexamethasone; Double-Blind Method; Humans; Hydrogels; Inflammation; Lens Implantation, Intraocular; Netilmicin; Ophthalmic Solutions; Postoperative Complications; Quality of Life; Treatment Outcome

To compare the efficacy and safety of preservative-free Netilmycin/Dexamethasone with that of preserved Tobramycin/Dexamethasone, postcataract surgery.. Prospective, randomized, single-blind study on patients submitted to phacoemulsification. During preoperatory visits, at 7 and 21 days conjunctival hyperemia, corneal edema, Tyndall, Shirmer I, corneal and conjunctival lissamine green and fluorescein staining, and intraocular pressure (IOP) were recorded. Postoperative pain (at day 7) and the subjective tolerability (at day 21) were investigated.. Eighty patients completed the study and the data collected were analyzed (44 on Netilmycin/Dexamethasone). Regarding the primary efficacy variable, intraocular inflammation, no microbial events were recorded, but aqueous flare was significantly lower with Tobramycin/Dexamethasone at 1 week (P = 0.002). Regarding secondary efficacy variables, conjunctival hyperemia was lower in patients under Tobramycin/Dexamethasone (P < 0.001), but corneal edema and ocular pain were similar. Regarding safety, no significant differences on ocular surface status were recorded. Both formulations were well tolerated, but Tobramycin/Dexamethasone caused an increased IOP at 1 week (P < 0.0001).. Both the studied fixed combinations are safe and effective in controlling postoperative inflammation and preventing postoperative ocular infections. Tobramycin/Dexamethasone has a quicker anti-inflammatory effect but needs IOP monitoring. Further studies on more patients using a sounder scientific design are needed to confirm our findings.

Topics: Aged; Aged, 80 and over; Anti-Bacterial Agents; Anti-Inflammatory Agents; Dexamethasone; Drug Combinations; Female; Follow-Up Studies; Humans; Inflammation; Male; Middle Aged; Netilmicin; Pain, Postoperative; Phacoemulsification; Postoperative Complications; Prospective Studies; Single-Blind Method; Time Factors; Tobramycin

A randomized comparative investigation was carried out in two equal groups of patients with pyo-inflammatory diseases of lower extremities (the total number 50 patients) in order to study effectiveness and tolerance to Netilmycin (1st group) and Gentamycin (2nd group) given in combination with Cefasolin. Clinical symptoms were estimated immediately after operation, in 3, 6 and 10-12 days after it. Bacteriological investigations were fulfilled immediately after operation, in 72 h and in 6-10 days after the beginning of antibacterial therapy. Clinical and biochemical investigations of blood were fulfilled before and in 10 days after the beginning of the treatment. Effectiveness of the treatment in the first group was 100%, in the second group--80%. In the second group the antibiotics were changed in 20% of cases and the average duration of hospitalization among the patients of this group was reliably longer that in the first group. The eradication rating of Netilmycin was higher than that of Gentamycin (25 strains from 25 and 20 from 25 respectively). Gentamycin had a pronounced nephrotoxic effect (elevation of the level of creatinin and urea of blood in dynamics by 21% and 32%), as compared with Netilmycin (9% and 3%). Total expenses to antibiotic therapy in the first group made up 97,650 rub, and in the second group 106,245 rub. Netilmycin in combination with Cefasolin was more effective for acute pyo-inflammatory diseases of lower extremities than a combination of Gentamycin with Cefasolin, it more rapidly resulted in reduction of clinical signs of inflammation, was better endured and more economical.

Topics: Adult; Aged; Anti-Bacterial Agents; Bacterial Infections; Cefazolin; Cost-Benefit Analysis; Female; Gentamicins; Humans; Inflammation; Lower Extremity; Male; Middle Aged; Netilmicin; Suppuration; Treatment Outcome