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

This study has been completed.
Sponsor:
Collaborators:
KEYRUS
VEEDA
Information provided by (Responsible Party):
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01089608
First received: March 17, 2010
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Moderate to Severe Chronic Blepharitis (Posterior and/or Anterior)
Drug: Azithromycin
Drug: Povidone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • Visual analogue scale [ Time Frame: D0 and D63 ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • VAS and ocular tolerance [ Time Frame: VAS : D7, D28 D57. Ocular tolerance : D7, D28, D57 and D63 ] [ Designated as safety issue: Yes ]

    Global Discomfort VAS + [(Redness of eyelid margin + Swelling of eyelid + Meibomian gland dysfunction + Quality of MG secretion)VAS / 4] ] / 2 To compare the efficacy of T1225 eye drops versus placebo with respect of the assessment of the patient's symptomatology evaluation, the ocular symptoms suggestive of blephatitis, the objective ocular signs ( and the global efficacy assessment by the investigator.

    To compare the ocular tolerance of T1225 eye drops versus placebo with respect of the assessment of the global local tolerance assessment by the investigator and by the patient.



Enrollment: 102
Study Start Date: March 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: T1225 1.5% - Azyter -

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089608

Locations
France
Hôpital Gabriel Montpied
Clermont-Ferrand, France, 63003
CHU de Bicêtre
Le Kremlin Bicêtre, France, 94270
C.H.N.O des XV-XX
Paris, France, 75012
Fondation Rothschild
Paris, France, 75019
CHU Hospices Civils
Strasbourg, France, 67000
CHU Bretonneau
Tours, France, 37044
Sponsors and Collaborators
Laboratoires Thea
KEYRUS
VEEDA
Investigators
Principal Investigator: Christophe BAUDOUIN, Professor
Principal Investigator: Frédéric Chiambaretta, Professor
Principal Investigator: Isabelle COCHEREAU, Professor
Principal Investigator: Catherine CREUZOT-GARCHER, Professor
Principal Investigator: Tristan BOURCIER, Professor
Principal Investigator: Marc LABETOULLE, Professor
Principal Investigator: Pierre-Jean PISELLA, Professor
  More Information

No publications provided

Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT01089608     History of Changes
Other Study ID Numbers: LT1225-PII-06/09, 2009-017388-41
Study First Received: March 17, 2010
Last Updated: April 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Laboratoires Thea:
Azyter in patients affected by chronic blepharitis.

Additional relevant MeSH terms:
Blepharitis
Eyelid Diseases
Eye Diseases
Povidone
Tetrahydrozoline
Azithromycin
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 15, 2014