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Completed

NCT Number: NCT01089608

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

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).

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Key information

Conditions

Blepharitis Eye Diseases Eyelid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

C.H.N.O des XV-XX

Paris, 75012, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Azithromycin

Drug

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 -

Povidone

Drug

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

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Collaborators

  • Keyrus Biopharma
  • VEEDA

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 18, 2010
Registry last updated
Nov 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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