Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00357383

Enrollment

Unknown

Registered

2006-07-27

Start date

2002-10-31

Completion date

2002-10-31

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 evaluate the ocular tolerance of T1225 1% and 1.5% eye drops versus vehicle after one instillation twice-daily (morning and evening), in one eye, during 3 days (from Day 0 to Day 2). To assess azithromycin tear, conjunctiva and plasmatic concentrations, after a 3-day treatment period

Detailed description

The aim of the present study was to compare ocular tolerance and safety after repeated instillations of T1225 1% and 1.5% eye drops and vehicle and to assess the residual azithromycin concentrations in tear, ocular conjunctiva and plasma samples, approximately 12 hours after the last Investigational Medicinal Product instillation.

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 subjective ocular symptom; * Normal ocular examination in both eyes (corrected visual acuity \>= 6/10, normal slit lamp examination, tear prism height \> 0.1mm, tear break-up time (BUT) \>= 10 seconds, lissamine green test score \< 4); * Registered, or agreed to be registered, in the national register of healthy volunteers

Exclusion criteria

* Ocular trauma, infection or inflammation within the last 3 months; * number of corneal stained punctuations Ocular trauma, infection or inflammation within the last 3 months; * number of corneal stained punctuations \>= 5; * blepharitis, conjunctivitis, uveitis; * contact lenses; * topical ocular treatment within the last month; * ocular laser within the last 3 months; * ocular surgery, including LASIK and PRK, within the last 12 months; * systemic macrolide within the last month; * medication during the study (except: paracetamol and contraceptives).

Design outcomes

Primary

Measure	Time frame
Ocular pharmacokinetic in tears	—

Secondary

Measure	Time frame
Tolerance	—

Outcome results

None listed

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