Dexamethasone-netilmicin: a new ophthalmic steroid-antibiotic combination. Efficacy and safety after cataract surgery.
OBJECTIVE
The purpose of this study was to evaluate both efficacy and safety of a new ophthalmic steroid-antibiotic fixed combination containing dexamethasone and netilmicin in the postsurgical management of cataract surgery.


METHODS
In total, 223 patients were randomly treated with dexamethasone 1 mg/ml plus netilmicin 3 mg/ml (n=148), or dexamethasone 1 mg/ml plus tobramycin 3 mg/ml (n=75, TOBRADEX) four times in a day for 7+/-1 days starting immediately after surgery. Efficacy (anterior chamber (AC) inflammation, conjunctival hyperaemia, corneal and lid oedema, ocular infection, pain, photophobia and tearing) and safety (burning, stinging, blurred vision, intraocular pressure, and visual acuity) were analysed in the operated eye after 1 and 7+/-1 days. A follow-up visit was performed at day 14+/-2. The extent of AC inflammation, measured by slit-lamp according to a standard scoring system, was used as primary efficacy parameter.


RESULTS
At the primary end point (day 7) both fixed combinations were equally effective in reducing postoperative inflammation. The safety profile of the dexamethasone/netilmicin combination was excellent with no evidence of poor local tolerance or adverse reaction.


CONCLUSIONS
A new fixed combination of dexamethasone and netilmicin was effective and safe in controlling ocular inflammation after cataract surgery.
Russo
S
S
Medical Department, SIFI S.p.A., Aci S.Antonio, Italy.
Papa
V
V
Di Bella
A
A
Favero
A
A
Radulescu
C
C
Gafencu
O
O
Carstocea
B
B
Milazzo
G
G
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D019072:Antibiotic Prophylaxis / Q000379:methods; D003907:Dexamethasone / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D015818:Eye Infections, Bacterial / Q000517:prevention & control; D005260:Female; D005938:Glucocorticoids / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009428:Netilmicin / Q000009:adverse effects / Q000627:therapeutic use*; D018918:Phacoemulsification; D011182:Postoperative Care / Q000379:methods; D011446:Prospective Studies; D013530:Surgical Wound Infection / Q000517:prevention & control; D014031:Tobramycin / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D014792:Visual Acuity
D000900:Anti-Bacterial Agents; D004338:Drug Combinations; D005938:Glucocorticoids; D009428:Netilmicin; D003907:Dexamethasone; D014031:Tobramycin