Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1 and 1.5% in 48 Healthy Volunteers

Comparison of the Ocular Tolerance, the Safety and the Ocular Pharmacokinetics After One Drop of Three Different Concentrations of T1225 (0.5% - 1.0% - 1.5%) in 48 Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00357539

Enrollment

Unknown

Registered

2006-07-27

Start date

2002-02-28

Completion date

2002-03-31

Last updated

2006-07-27

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 compare the ocular tolerance, safety and ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225.

Detailed description

The present phase I clinical trial was performed in order to investigate the ocular tolerance, safety and the ocular pharmacokinetics of a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.

Interventions

DRUGAzithromycin (T1225)

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 or female aged from 18 to 45 years old; * Written informed consent; * Healthy volunteers (without any ocular symptom); * Normal ocular examination in both eyes (corrected visual acuity (VA) \>= 6/10 - slit lamp examination without clinical relevant abnormalities - tear break-up time (BUT) \>= 10 seconds - lachrymal secretion in the Schirmer test \>= 10 mm in 5 minutes - lissamine green test total score \< 4).

Exclusion criteria

* Ocular trauma, infection or inflammation within the last 3 months; * Conjunctival hyperaemia score \>= 2, watering score \>= 2, folliculo-papillary conjunctivitis score \>= 2, number of fluorescein-stained punctuations \>= 10; * Blepharitis, conjunctivitis, uveitis; * Ocular laser treatment within the last 3 months; * Ocular surgery, including LASIK and PRK, within the last 12 months; * Topical ocular treatment during the last month; * Ocular antibiotics within the last 7 days; * Medication during the study (except paracetamol and contraceptives).

Design outcomes

Primary

Measure	Time frame
Subjective ocular symptoms	—
Objective ocular symptoms	—

Secondary

Measure	Time frame
Systemic adverse events	—
Ocular adverse events	—
Ocular pharmacokinetic	—

Countries

France

Outcome results

None listed

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