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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01089608
First Posted: March 18, 2010
Last Update Posted: November 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Keyrus Biopharma
VEEDA
Information provided by (Responsible Party):
Laboratoires Thea
  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
Blepharitis Drug: Azithromycin Drug: Povidone Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • Visual Analogue Scale (VAS - Ranges 0-100 mm) [ Time Frame: 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)


Enrollment: 93
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01089608


Locations
France
C.H.N.O des XV-XX
Paris, France, 75012
Sponsors and Collaborators
Laboratoires Thea
Keyrus Biopharma
VEEDA
Investigators
Principal Investigator: Christophe BAUDOUIN, Professor
  More Information

Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT01089608     History of Changes
Other Study ID Numbers: LT1225-PII-06/09
2009-017388-41 ( EudraCT Number )
First Submitted: March 17, 2010
First Posted: March 18, 2010
Results First Submitted: October 7, 2014
Results First Posted: November 4, 2014
Last Update Posted: November 4, 2014
Last Verified: October 2014

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

Additional relevant MeSH terms:
Blepharitis
Eyelid Diseases
Eye Diseases
Ophthalmic Solutions
Tetrahydrozoline
Povidone
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Plasma Substitutes
Blood Substitutes