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Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis

NCT01089608 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2014-11-04

Study results available
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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).

Conditions

  • Blepharitis

Interventions

DRUG

Azithromycin

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.

DRUG

Povidone

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.

Sponsors & Collaborators

  • Keyrus Biopharma

    collaborator OTHER

  • VEEDA

    collaborator UNKNOWN

  • Laboratoires Thea

    lead INDUSTRY

Principal Investigators

  • Christophe BAUDOUIN, Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01089608 on ClinicalTrials.gov