Ocular Tolerance, Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1.0, 1.5% in 48 Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT00357292
First received: July 25, 2006
Last updated: July 26, 2006
Last verified: July 2006
  Purpose

To compare the ocular tolerance, the safety and the ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225 after one drop instillation


Condition Intervention Phase
Eye Infections, Bacterial
Drug: Azithromycin (T1225)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Comparison of the Ocular Tolerance, the Safety and the Ocular Pharmacokinetics After One Drop of Three Different Concentrations of T1225 (0.5% - 1.0% - 1.5%) in 48 Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • Ocular subjective symptoms
  • Ocular objective symptoms

Secondary Outcome Measures:
  • Ocular pharmacokinetic.
  • Ocular and systemic adverse events.

Study Start Date: March 2002
Estimated Study Completion Date: April 2002
Detailed Description:

The aim of the present study was to compare the ocular tolerance, safety and the ocular pharmacokinetics after a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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;
  • Blepharitis;
  • Conjunctival hyperaemia (score >= 2 +);
  • Watering (score >= 2);
  • Contact lenses;
  • Ocular surgery, including LASIK and PRK, within the last 12 months;
  • Topical ocular treatment within the last month;
  • Systemic antibiotics within the last 7 days;
  • Any medication during the study (except: Paracetamol and contraceptives).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357292

Sponsors and Collaborators
Laboratoires Thea
Investigators
Principal Investigator: Khalid TABBARA, Professor The Eye Center, Riyadh (Saudi Arabia)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00357292     History of Changes
Other Study ID Numbers: LT1225-PI1-09/01(AS)
Study First Received: July 25, 2006
Last Updated: July 26, 2006
Health Authority: United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health

Additional relevant MeSH terms:
Bacterial Infections
Eye Infections
Eye Infections, Bacterial
Infection
Eye Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014