NCT00357539

CompletedPhase 1

Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5...

Laboratoires Thea Source

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Other study identifiers

Sponsor study identifier

LT1225-PI1-09/01(F)

Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

1

Timeline

Study Start

February 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

March 2002

Date type not reported

This date has not been verified as actual or estimated.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): Not reported
Study completion date: March 2002
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 2002
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
March 2002
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
July 25, 2006
Actual (reported)
First Posted
July 27, 2006
Actual (reported)

Last Updated: July 27, 2006
Status Verified: July 2006
Last Update Submitted: July 26, 2006

Conditions

Eye Infections, Bacterial

Outcome Measures

Primary Outcomes (2)

Subjective ocular symptoms
Objective ocular symptoms

Secondary Outcomes (3)

Systemic adverse events
Ocular adverse events
Ocular pharmacokinetic

Interventions

Azithromycin (T1225)Drug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 45 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Male or female aged from 18 to 45 years old;
Written informed consent;

Sponsors & Collaborators

Laboratoires Thea
Industrylead

Study Sites (1)

Unité de Pharmacologie Clinique

Clermont-Ferrand, 63009, France

MeSH Terms

Conditions

Eye Infections, Bacterial

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsEye InfectionsEye Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

Claude DUBRAY, Professor
Unité de Pharmacologie Clinique - Clermont-Ferrand (France)
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

July 25, 2006

First Posted

July 27, 2006

Study Start

February 2002

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

March 2002

Date type not reported

NCT00357773

Efficacy and Safety of T1225 1.5% Versus Tobramycin 0.3 % in the Treatment of Purulent Bacterial Conjunctivitis

Phase 3Completed

NCT04981860

Comparison of Conjunctival Antimicrobial Activity and Patient Comfort Between Topical Hypochlorous Acid (Avenova) and Betadine

Phase 4Suspended

NCT00324168

Steroids for Corneal Ulcers Trial

Phase 4Completed

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).

You may not qualify if:

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).

Contact the study team to confirm eligibility.

This date has not been verified as actual or estimated.

Last Updated

July 27, 2006

Record last verified: 2006-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00357539
Data provider: ClinicalTrials.gov
Source updated: 2006-07-27
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:32 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations