CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 125 enrolled
Drug / intervention
Levofloxacin + Dexamethasone +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03740659
NCT03740659Phase 2Completed
CompareCT.gov

Aqueous Humour Concentrations After Topical apPlication of combinEd Levofloxacin-dexamethasone Eye dRops and of Its Single Components: a randoMized, assEssor-blinded, Parallel-group Study in Patients Undergoing Cataract Surgery - iPERME

NTC srl·interventional·Posted Nov 14, 2018·Updated Jul 7, 2020

In Brief

A Phase 2 clinical trial evaluating Levofloxacin + Dexamethasone, Levofloxacin, and 1 other intervention for Cataract. Completed, enrolled 125 participants across 2 sites.

Detailed Summary

The purpose of this study is to evaluate the penetration of levofloxacin and dexamethasone 21-phosphate into the aqueous humour after ocular administration in combination or as single active ingredients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCataract
CountriesItaly
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 14, 2018
Enrollment StartSep 4, 2018
Primary CompletionDec 6, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.6 years ago

Interventions

Levofloxacin + Dexamethasonedrug

Levofloxacin + Dexamethasone ophthalmic solution + dexamethasone 21-phosphate administered twice: 90(±15) min. and 60(±15) min. before limbal paracentesis.

Levofloxacindrug

Levofloxacin ophthalmic solution (Oftaquix®) administered twice: 90 (±15) min. and 60 (±15) min. before limbal paracentesis).

Dexamethasonedrug

Dexamethasone ophthalmic solution (Tamesad®) administered twice: 90 (±15) min. and 60 (±15) min. before Limbal paracentesis.