---
title: Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis
nct_id: NCT01089608
overall_status: COMPLETED
phase: PHASE2
sponsor: Laboratoires Thea
study_type: INTERVENTIONAL
primary_condition: Blepharitis
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01089608.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01089608"
ct_last_update_post_date: 2014-11-04
last_seen_at: "2026-05-12T06:48:06.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis

**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)

**NCT ID:** [NCT01089608](https://clinicaltrials.gov/study/NCT01089608)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 93
- **Lead Sponsor:** Laboratoires Thea
- **Collaborators:** Keyrus Biopharma, VEEDA
- **Conditions:** Blepharitis
- **Start Date:** 2010-03
- **Completion Date:** 2012-06
- **CT.gov Last Update:** 2014-11-04

## 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).

## Detailed 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).

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Unifluid** (PLACEBO_COMPARATOR) — Eye drops in Single Dose Unit
- **Azithromycin** (EXPERIMENTAL) — Eye drops Single dose unit

## 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.
- **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.

## Primary Outcomes

- **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)

## Locations (1)

- C.H.N.O des XV-XX, Paris, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.c.h.n.o des xv-xx|paris||france` — added _(2026-05-12)_

---

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