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

NCT01089608 | Completed Phase 2 Results

• 2 other identifiers: LT1225-PII-06/092009-017388-41
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Blepharitis

Keywords

Azyter in patients affected by chronic blepharitis.

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Unifluid

PLACEBO COMPARATOR

Eye drops in Single Dose Unit

Drug: Povidone

Azithromycin

EXPERIMENTAL

Eye drops Single dose unit

Drug: Azithromycin

Interventions

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.

Also known as: T1225 1.5% - Azyter -

Azithromycin

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.

Also known as: Unifluid

Unifluid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of moderate to severe chronic blepharitis (posterior and/or anterior) in at least one eligible eye

You may not qualify if:

• Monophtalmia
• Eyelid dysfunction
• Facial paralysis.
• Severe dry eye syndrome.
• Ocular metaplasia.
• Filamentous keratitis
• Schirmer test \< 5 mm.
• Best far corrected visual acuity \< 1/10.

Sponsors & Collaborators

• Laboratoires Thea: lead
• Keyrus Biopharma: collaborator
• VEEDA: collaborator

Study Sites (1)

C.H.N.O des XV-XX

Paris, 75012, France

Location

MeSH Terms

Conditions

Blepharitis

Interventions

Azithromycin; Povidone

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr Pascale POULIQUEN
• Organization: Laboratoires Thea

p.pouliquen@laboratoires-thea.fr

0473981436

Study Officials

• Christophe BAUDOUIN, Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 18, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 4, 2014
• Results First Posted: November 4, 2014

Record last verified: 2014-10

Locations

FR (1)