At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 91 enrolled
Drug / intervention
Oxatrexdrug
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.
Concentration of Ofloxacin Into the Aqueous Humour of Patients After Topical Instillation According to the Severity of Dry Eye Disease
In Brief
A Phase 4 clinical trial evaluating Oxatrex for Dry Eye Disease. Completed, enrolled 91 participants across 1 site.
Detailed Summary
After topical installation of one drop of 0.3% commercially available ofloxacin (Oxatrex®) four times at intervals of 15min in catarract patients with Dry Eye Disease, aqueous humour samples will be collected intraoperatively, one hour after the last installation. Concentration of ofloxacin in aqueous humour will be measured by HPLC-MS/MS.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesGreece
CollaboratorsUniversity of Patras
Timeline
Phase 4CompletedFinished
2020202120222023202420252026
Enrollment StartSep 2019
Primary CompletionJan 2022
First PostedJan 2022
TodayJul 2026
First PostedJan 28, 2022
Enrollment StartSep 24, 2019
Primary CompletionJan 24, 2022
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 4.4 years ago
Interventions
Oxatrexdrug
0.3% ofloxacin eye drops in single doses