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

Primary Purpose

Blepharitis

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Azithromycin
Povidone
Sponsored by
Laboratoires Thea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blepharitis focused on measuring Azyter in patients affected by chronic blepharitis.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-Diagnosis of moderate to severe chronic blepharitis (posterior and/or anterior) in at least one eligible eye

Exclusion Criteria:

  • Monophtalmia
  • Eyelid dysfunction
  • Facial paralysis.
  • Severe dry eye syndrome.
  • Ocular metaplasia.
  • Filamentous keratitis
  • Schirmer test < 5 mm.
  • Best far corrected visual acuity < 1/10.

Sites / Locations

  • C.H.N.O des XV-XX

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Unifluid

Azithromycin

Arm Description

Eye drops in Single Dose Unit

Eye drops Single dose unit

Outcomes

Primary Outcome Measures

Visual Analogue Scale (VAS - Ranges 0-100 mm)
The primary objective is to evaluate the efficacy of the treatment by the change from baseline (Day 0) to Day 63 (± 3 Days) of the global ocular discomfort (Visual Analogue Scale) (Decrease of VAS value = better outcome)

Secondary Outcome Measures

Full Information

First Posted
March 17, 2010
Last Updated
November 3, 2014
Sponsor
Laboratoires Thea
Collaborators
Keyrus Biopharma, VEEDA
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1. Study Identification

Unique Protocol Identification Number
NCT01089608
Brief Title
Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Thea
Collaborators
Keyrus Biopharma, VEEDA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
Detailed Description
Currently, topical antibiotic ointments are used for blepharitis. They provide prolonged contact time with the lid margin but with little penetration into eyelid tissue. Azithromycin eye drops may offer on advantage over these preparations because azithromycin achieves sustained high concentration in various ocular tissues including the lid margin. Patients will be treated during 7 days (1 drop twice daily the first day following by one drop once daily for 6 days) following by a period of 2 weeks without treatment. This therapeutic scheme will be repeated two times. Efficacy will be evaluated by change from baseline (Day 0) to Day 63 ± 3 Days of the global ocular discomfort evaluation (VAS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharitis
Keywords
Azyter in patients affected by chronic blepharitis.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unifluid
Arm Type
Placebo Comparator
Arm Description
Eye drops in Single Dose Unit
Arm Title
Azithromycin
Arm Type
Experimental
Arm Description
Eye drops Single dose unit
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Other Intervention Name(s)
T1225 1.5% - Azyter -
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Povidone
Other Intervention Name(s)
Unifluid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS - Ranges 0-100 mm)
Description
The primary objective is to evaluate the efficacy of the treatment by the change from baseline (Day 0) to Day 63 (± 3 Days) of the global ocular discomfort (Visual Analogue Scale) (Decrease of VAS value = better outcome)
Time Frame
Baseline and D63 (D63 minus baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -Diagnosis of moderate to severe chronic blepharitis (posterior and/or anterior) in at least one eligible eye Exclusion Criteria: Monophtalmia Eyelid dysfunction Facial paralysis. Severe dry eye syndrome. Ocular metaplasia. Filamentous keratitis Schirmer test < 5 mm. Best far corrected visual acuity < 1/10.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe BAUDOUIN, Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
C.H.N.O des XV-XX
City
Paris
ZIP/Postal Code
75012
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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