Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers
This study has been completed.
Sponsor:
Laboratoires Thea
Information provided by:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT00356772
First received: July 25, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
To evaluate azithromycin ocular conjunctiva concentrations 7 and 14 days after treatment initiation.
To assess ocular and systemic tolerance/safety and azithromycin tear concentrations on Day 7
| Condition | Intervention | Phase |
|---|---|---|
|
Eye Infections, Bacterial |
Drug: Azithromycin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Comparison of Azithromycin Level in Tears and in Conjunctiva After Repeated Instillations of T1225 1.5% Eye Drops or After a Single Per Os Administration of Zithromax® (Azithromycin 1g), in 36 Healthy Volunteers |
Resource links provided by NLM:
Further study details as provided by Laboratoires Thea:
Primary Outcome Measures:
- Azithromycin Ocular Conjunctiva Concentrations on Days 7 and 14.
- Azithromycin Tear Concentrations on Day 7.
Secondary Outcome Measures:
- Tolerance
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | March 2003 |
The aim of the present study was to compare azithromycin tear and conjunctival ocular concentrations after one instillation of T1225 1.5% eye drops, twice a day during one day versus one instillation of T1225 1.5% eye drops, twice a day during 3 days versus an oral single dose of 1g azithromycin.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Written informed consent;
- Healthy volunteers;
- Registered in the national register of healthy volunteers;
- Male or female aged from 18 to 45 years old;
- Able to understand the study instructions;
- Likely to comply with the study schedule and treatment;
- Normal subjective ocular symptoms, Schirmer test > 10 mm in 5 min and corrected visual acuity >= 6/10 in both eyes
Exclusion Criteria:
- Ocular trauma, infection or inflammation within the last 3 months;
- Blepharitis;
- Conjunctival hyperaemia (score >= 2);
- Fluorescein-stained punctuations (score >= 1b);
- Hypersensitivity to one of the products used in the study;
- Clinically relevant allergy;
- Medical or surgical history incompatible with the study;
- Recent acute illness;
- Ocular surgery, including LASIK, LASEK and PRK within the last 12 months;
- Other ocular lasers or Zithromax® or Azadose® within the last 3 months;
- Systemic antibiotics and ocular medications within the last month;
- Contact lenses within the last week;
- Any medication on Day 0 and during the study (except paracetamol and contraceptives).
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00356772 History of Changes |
| Other Study ID Numbers: | LT1225-PI4-11/02(F) |
| Study First Received: | July 25, 2006 |
| Last Updated: | July 25, 2006 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
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 May 22, 2013