CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 93 enrolled
Drug / intervention
Azithromycin +1 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/NCT01089608
NCT01089608Phase 2Completed
CompareCT.gov

Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis (Pilot Phase II Clinical Study, Multicentre, Randomised, Double Masked, Comparative, 2 X 40 Patients)

Laboratoires Thea·interventional·Posted Mar 18, 2010·Updated Nov 4, 2014

In Brief

A Phase 2 clinical trial evaluating Azithromycin and Povidone for Blepharitis. Completed, enrolled 93 participants across 1 site.

Detailed Summary

The primary objective of this study is to demonstrate the efficacy of T1225 eye drops versus placebo eye drops on the global ocular discomfort (VAS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBlepharitis
CountriesFrance
CollaboratorsKeyrus Biopharma, VEEDA

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 18, 2010
Enrollment StartMar 1, 2010
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.3 years ago

Interventions

Azithromycindrug

Eye drops, Dosage : 1.5% 1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.

Povidonedrug

Eye drops Single dose unit 1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.