Phase 2
N=93
Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis
Blepharitis
Bottom Line
View on ClinicalTrials.gov: NCT01089608 ↗Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Visual Analogue Scale (VAS - Ranges 0-100 mm) — 36.5; 28.5 units on a scale (from 0 to 100 mm) — p=0.072
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Azithromycin (Drug); Povidone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Laboratoires Thea
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analogue Scale (VAS - Ranges 0-100 mm) |
36.5; 28.5 | 0.072 |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01089608). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.