Ocular Tolerance, Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1.0, 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

NCT00357292

Enrollment

Unknown

Registered

2006-07-27

Start date

2002-03-31

Completion date

2002-04-30

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, the safety and the ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225 after one drop instillation

Detailed description

The aim of the present study was to compare the ocular tolerance, safety and the ocular pharmacokinetics after 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; * Blepharitis; * Conjunctival hyperaemia (score \>= 2 +); * Watering (score \>= 2); * Contact lenses; * Ocular surgery, including LASIK and PRK, within the last 12 months; * Topical ocular treatment within the last month; * Systemic antibiotics within the last 7 days; * Any medication during the study (except: Paracetamol and contraceptives).

Design outcomes

Primary

Measure	Time frame
Ocular subjective symptoms	—
Ocular objective symptoms	—

Secondary

Measure	Time frame
Ocular pharmacokinetic.	—
Ocular and systemic adverse events.	—

Outcome results

None listed

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