NCT00357383

CompletedPhase 1

Study of the Ocular Safety After Repeated Instillations of T...

Laboratoires Thea Source

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Other study identifiers

Sponsor study identifier

LT1225-PI3-07/02(F)

Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

0 countries

Sites

N/A

Timeline

Study Start

October 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

October 2002

Date type not reported

This date has not been verified as actual or estimated.

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

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: October 2002
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 0 countries · 0 sites

Trial Relationships

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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
October 2002
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
October 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 (1)

Ocular pharmacokinetic in tears

Secondary Outcomes (1)

Tolerance

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

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

Didier CHASSARD, Dr
ASTER, Paris, 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

October 2002

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

October 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 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

You may not qualify if:

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).

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: NCT00357383
Data provider: ClinicalTrials.gov
Source updated: 2006-07-27
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:18:07 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record