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Clinical Trial 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


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00357383
Study type Interventional
Source Laboratoires Thea
Contact
Status Completed
Phase Phase 1
Start date October 2002
Completion date October 2002

See also
  Status Clinical Trial Phase
Completed NCT00324168 - Steroids for Corneal Ulcers Trial Phase 4
Completed NCT00356850 - Ocular Pharmacokinetics After a Single Drop Instillation of T1225 0.5, 1, 1.5% in 91 Healthy Volunteers Phase 1
Completed NCT00357292 - Ocular Tolerance, Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1.0, 1.5% in 48 Healthy Volunteers Phase 1
Completed NCT00356772 - Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers Phase 1
Completed NCT00357539 - Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1 and 1.5% in 48 Healthy Volunteers Phase 1
Recruiting NCT04981860 - Comparison of Conjunctival Antimicrobial Activity and Patient Comfort Between Topical Hypochlorous Acid (Avenova) and Betadine Phase 4