CClinicalTrials.gg
Sign In
CompletedNCT00357383Updated Jul 27, 2006

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

A Phase 1 interventional study of Azithromycin (T1225) in Eye Infections, Bacterial, sponsored by Laboratoires Thea. Completed. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-07-27.

Sponsored by Laboratoires Thea · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Eye Infections, Bacterial
03

In context

Bacterial Infections

658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.

Browse Bacterial Infections studies →

Lead sponsor

Laboratoires Thea is the lead sponsor of 63 studies on the registry; 7 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts 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

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).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double

Interventions

  • DrugAzithromycin (T1225)
06

What researchers measure

Primary outcomes

  1. Ocular pharmacokinetic in tears

Secondary outcomes

  1. Tolerance

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00357383
Lead sponsor
Laboratoires Thea
First posted
Jul 27, 2006
Start date
Oct 2002
Completion
Oct 2002
Last update
Jul 27, 2006

Study contacts

Didier CHASSARD, Dr
principal investigator · ASTER, Paris, France
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2006. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Bacterial Infections→

Other studies from this sponsor

Laboratoires Thea

Start the discussion