Ocular Pharmacokinetics After a Single Drop Instillation of T1225 0.5, 1, 1.5% in 91 Healthy Volunteers

Ocular Pharmacokinetics After a Single Drop Instillation, in Each Eye of One of Three Different Concentrations of T1225 (0.5% - 1% - 1.5% Dihydrate) in 91 Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00356850

Enrollment

Unknown

Registered

2006-07-26

Start date

2002-05-31

Completion date

2002-06-30

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 tear concentrations after instillation of one drop of one of the three T1225 concentrations (0.5%, 1% and 1.5%) and to evaluate the ocular safety.

Detailed description

The aim of the present study was to compare azithromycin tear ocular concentrations after a single instillation of three different T1225 concentrations in order to determine early azithromycin tear concentration and to assess the T1225 concentration, which allowed having the higher azithromycin tear concentration, 24 hours after a single instillation.

Interventions

DRUGAzithromycin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Male/female aged from 18 to 45 years; * Written informed consent; * Healthy volunteers without any subjective ocular symptom; * Corrected visual acuity \>= 6/10; * Registered in the national register of healthy volunteers

Exclusion criteria

* Ocular trauma, infection or inflammation within the last 3 months; * Conjunctival hyperaemia (score \>= 2); * Folliculo-papillary conjunctivitis (score \>= 2); * Topical ocular treatment within the last month; * Ocular surgery, including LASIK and PRK, within the last 12 months; * Other ocular laser within the last 3 months; * Zithromax® and Azadose® within the last 3 months; * Medication during the study (except: paracetamol, contraceptives

Design outcomes

Primary

Measure	Time frame
Area Under the Curve from 0 to 24 hours (AUC0-24h)	—
Elimination half-life (t1/2)	—
Maximum Concentration (Cmax)	—
Concentration 24 hours after instillation (C24h)	—

Secondary

Measure	Time frame
Tolerance	—

Outcome results

None listed

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