Posters

Leader 7 study: one week levofloxacin/dexamethasone followed by one week dexamethasone versus two weeks tobramycin/dexamethasone after cataract surgery – results of subgroup analysis

Poster Details

First Author: F.Bandello ITALY

Co Author(s):                        

Abstract Details

Purpose:

LEADER 7 was an international, multicenter, randomized, blinded-assessor, parallel-group clinical study and evaluated non-inferiority of a short term antibiotic/anti-inflammatory treatment (1-week with a combination of levofloxacin 5 mg/mL and dexamethasone 21-phosphate 1 mg/mL) followed by 1-week treatment with dexamethasone alone versus a standard 2-weeks antibiotic/anti-inflammatory treatment (tobramycin 3 mg/mL + dexamethasone 1 mg/mL) in preventing and treating ocular inflammation and in preventing infection after cataract surgery. All drugs were administered at the dose of 1 drop QID.

Setting:

In this study 863 adult male and female patients were enrolled in 53 centers in Italy, Germany, Spain and Russia. At home, patients self-administered eye drops and recorded doses for compliance assessment.

Methods:

After cataract surgery, patients underwent visits at the clinics on Day 4, Day 8 and Day 15 (end of study - EOS) to evaluate efficacy, safety and tolerability. Primary endpoint was the proportion of patients without signs of anterior chamber inflammation (sum of cells and flares = 0) after 14 days of treatment. A post-hoc analysis was performed in order to evaluate potential differences in anti-inflammatory efficacy by gender, age, diagnosis of diabetes, intracameral antibiotic administration and concomitant use of NSAIDs subgroups.

Results:

At EOS 95.1% of patients in test arm and 94.9% in control group showed no inflammatory signs (estimate=0.0028; 95%CI:-0.0275/0.0331). There were no cases of endophthalmitis. Subgroups were identified by gender (42% males, 58% females in test vs 39.2%, 60.8%), age (17.7% <65yo, 43.8% 65-75yo, 38.5% >75yo in test vs 18.1% <65yo, 44.5% 65-75yo, 37.4% >75yo), diabetes (16.9% in test vs 17.3%), intracameral antibiotics (80% in test vs 80.2%), NSAIDs concomitant use (7.85% in test vs 8.91%). Non inferiority between groups was confirmed except for NSAIDs use: no inflammatory signs in 97.2% of patients in test vs 78.9% (estimate=0.1827; 95%CI:0.0425/0.3280).

Conclusions:

Current study evidenced for the first time that a new treatment strategy after cataract surgery, based on 1-week levofloxacin plus dexamethasone followed by 1-week dexamethasone alone, was effective in reducing cataract surgery-induced inflammation. Non inferiority between groups was confirmed for all subgroups analyzed except for NSAIDs concomitant use. A significantly higher number of patients had no inflammatory signs at EOS in test arm when NSAIDs where used concomitantly. This result could be just a chance finding explained by the remarkably low number of patients with concomitant use of NSAIDs in both groups.

Financial Disclosure:

None