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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2002-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Eye Infections, Bacterial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Azithromycin (T1225)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Didier CHASSARD, Dr

Role: PRINCIPAL_INVESTIGATOR

ASTER, Paris, France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LT1225-PI3-07/02(F)

Identifier Type: -

Identifier Source: org_study_id