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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2002-03-31

Brief Summary

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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

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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.

Conditions

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Eye Infections, Bacterial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Azithromycin (T1225)

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Claude DUBRAY, Professor

Role: PRINCIPAL_INVESTIGATOR

Unité de Pharmacologie Clinique - Clermont-Ferrand (France)

Locations

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Unité de Pharmacologie Clinique

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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LT1225-PI1-09/01(F)

Identifier Type: -

Identifier Source: org_study_id