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

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Thea Pharma

Status and phase

Completed
Phase 2

Conditions

Blepharitis

Treatments

Drug: Povidone
Drug: Azithromycin

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01089608
LT1225-PII-06/09
2009-017388-41 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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).

Enrollment

93 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

93 participants in 2 patient groups, including a placebo group

Unifluid
Placebo Comparator group
Description:
Eye drops in Single Dose Unit
Treatment:
Drug: Povidone
Azithromycin
Experimental group
Description:
Eye drops Single dose unit
Treatment:
Drug: Azithromycin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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