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

Blepharitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01089608
• Other study ID #: LT1225-PII-06/09
• Secondary ID: 2009-017388-41
• Status: Completed
• Phase: Phase 2
• First received: March 17, 2010
• Last updated: November 3, 2014
• Start date: March 2010
• Est. completion date: June 2012

Study information

• Verified date: October 2014
• Source: Laboratoires Thea
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	C.H.N.O des XV-XX	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Laboratoires Thea	Keyrus, VEEDA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS - Ranges 0-100 mm)	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)	Baseline and D63 (D63 minus baseline)	No