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

Sponsor
Laboratoires Thea (Industry)
Overall Status
Completed
CT.gov ID
NCT01089608
Collaborator
Keyrus Biopharma (Other), VEEDA (Other)
93
Enrollment
1
Location
2
Arms
27
Duration (Months)
3.4
Patients Per Site Per Month

Study Details

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).

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
93 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

ArmIntervention/Treatment
Placebo Comparator: Unifluid

Eye drops in Single Dose Unit

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.
Other Names:
  • Unifluid
  • Experimental: Azithromycin

    Eye drops Single dose unit

    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.
    Other Names:
  • T1225 1.5% - Azyter -
  • Outcome Measures

    Primary Outcome Measures

    1. Visual Analogue Scale (VAS - Ranges 0-100 mm) [Baseline and D63 (D63 minus baseline)]

      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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1C.H.N.O des XV-XXParisFrance75012

    Sponsors and Collaborators

    • Laboratoires Thea
    • Keyrus Biopharma
    • VEEDA

    Investigators

    • Principal Investigator: Christophe BAUDOUIN, Professor,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Laboratoires Thea
    ClinicalTrials.gov Identifier:
    NCT01089608
    Other Study ID Numbers:
    • LT1225-PII-06/09
    • 2009-017388-41
    First Posted:
    Mar 18, 2010
    Last Update Posted:
    Nov 4, 2014
    Last Verified:
    Oct 1, 2014
    Keywords provided by Laboratoires Thea
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleUnifluidAzithromycin
    Arm/Group DescriptionEye drops in Single Dose Unit 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.Eye drops Single dose unit 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.
    Period Title: Overall Study
    STARTED4350
    COMPLETED4344
    NOT COMPLETED06

    Baseline Characteristics

    Arm/Group TitleUnifluidAzithromycinTotal
    Arm/Group DescriptionEye drops in Single Dose Unit 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.Eye drops Single dose unit 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.Total of all reporting groups
    Overall Participants435093
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    56.8
    (16.2)
    55.7
    (16.1)
    56.2
    (16.1)
    Sex: Female, Male (Count of Participants)
    Female
    26
    60.5%
    25
    50%
    51
    54.8%
    Male
    17
    39.5%
    25
    50%
    42
    45.2%

    Outcome Measures

    1. Primary Outcome
    TitleVisual Analogue Scale (VAS - Ranges 0-100 mm)
    DescriptionThe 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 FrameBaseline and D63 (D63 minus baseline)

    Outcome Measure Data

    Analysis Population Description
    Modified ITT set: all randomised patients with at least one eligible treated eye, for whom any follow-up efficacy data are available.
    Arm/Group TitleUnifluidAzithromycin
    Arm/Group DescriptionEye drops in Single Dose Unit 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.Eye drops Single dose unit 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.
    Measure Participants4350
    Least Squares Mean (95% Confidence Interval) [units on a scale (from 0 to 100 mm)]
    36.5
    28.5
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Unifluid, Azithromycin
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesisp-Value0.072
    Comments
    MethodMixed Models Analysis
    Comments
    Method of EstimationEstimation ParameterMean Difference (Net)
    Estimated Value-8.01
    Confidence Interval (2-Sided) 95%
    -16.30 to 0.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group TitleUnifluidAzithromycin
    Arm/Group DescriptionEye drops in Single Dose Unit 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.Eye drops Single dose unit 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.
    All Cause Mortality
    UnifluidAzithromycin
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN)
    Serious Adverse Events
    UnifluidAzithromycin
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/43 (0%) 0/50 (0%)
    Other (Not Including Serious) Adverse Events
    UnifluidAzithromycin
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/43 (0%) 0/50 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    All the results of the Trial are the sole and exclusive property of THEA, and cannot be used in whatever form without prior written agreement of THEA.

    Results Point of Contact

    Name/TitleDr Pascale POULIQUEN
    OrganizationLaboratoires Thea
    Phone0473981436
    Emailp.pouliquen@laboratoires-thea.fr
    Responsible Party:
    Laboratoires Thea
    ClinicalTrials.gov Identifier:
    NCT01089608
    Other Study ID Numbers:
    • LT1225-PII-06/09
    • 2009-017388-41
    First Posted:
    Mar 18, 2010
    Last Update Posted:
    Nov 4, 2014
    Last Verified:
    Oct 1, 2014