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

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ClinicalTrials.gov Identifier: NCT00357292
Recruitment Status : Completed
First Posted : July 27, 2006
Last Update Posted : July 27, 2006
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Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Eye Infections, Bacterial Drug: Azithromycin (T1225) Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : March 2002
Estimated Study Completion Date : April 2002

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U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Ocular subjective symptoms
  2. Ocular objective symptoms

Secondary Outcome Measures :
  1. Ocular pharmacokinetic.
  2. Ocular and systemic adverse events.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357292

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

ClinicalTrials.gov Identifier: NCT00357292     History of Changes
Other Study ID Numbers: LT1225-PI1-09/01(AS)
First Posted: July 27, 2006    Key Record Dates
Last Update Posted: July 27, 2006
Last Verified: July 2006

Additional relevant MeSH terms:
Bacterial Infections
Eye Infections
Eye Infections, Bacterial
Eye Diseases