Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers

Comparison of Azithromycin Level in Tears and in Conjunctiva After Repeated Instillations of T1225 1.5% Eye Drops or After a Single Per Os Administration of Zithromax® (Azithromycin 1g), in 36 Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00356772

Enrollment

Unknown

Registered

2006-07-26

Start date

2003-02-28

Completion date

2003-03-31

Last updated

2006-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Infections, Bacterial

Brief summary

To evaluate azithromycin ocular conjunctiva concentrations 7 and 14 days after treatment initiation. To assess ocular and systemic tolerance/safety and azithromycin tear concentrations on Day 7

Detailed description

The aim of the present study was to compare azithromycin tear and conjunctival ocular concentrations after one instillation of T1225 1.5% eye drops, twice a day during one day versus one instillation of T1225 1.5% eye drops, twice a day during 3 days versus an oral single dose of 1g azithromycin.

Interventions

DRUGAzithromycin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Written informed consent; * Healthy volunteers; * Registered in the national register of healthy volunteers; * Male or female aged from 18 to 45 years old; * Able to understand the study instructions; * Likely to comply with the study schedule and treatment; * Normal subjective ocular symptoms, Schirmer test \> 10 mm in 5 min and corrected visual acuity \>= 6/10 in both eyes

Exclusion criteria

* Ocular trauma, infection or inflammation within the last 3 months; * Blepharitis; * Conjunctival hyperaemia (score \>= 2); * Fluorescein-stained punctuations (score \>= 1b); * Hypersensitivity to one of the products used in the study; * Clinically relevant allergy; * Medical or surgical history incompatible with the study; * Recent acute illness; * Ocular surgery, including LASIK, LASEK and PRK within the last 12 months; * Other ocular lasers or Zithromax® or Azadose® within the last 3 months; * Systemic antibiotics and ocular medications within the last month; * Contact lenses within the last week; * Any medication on Day 0 and during the study (except paracetamol and contraceptives).

Design outcomes

Primary

Measure	Time frame
Azithromycin Ocular Conjunctiva Concentrations on Days 7 and 14.	—
Azithromycin Tear Concentrations on Day 7.	—

Secondary

Measure	Time frame
Tolerance	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026