NCT00356772CompletedPhase 1
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Laboratoires Thea
- Primary Endpoint
- Azithromycin Ocular Conjunctiva Concentrations on Days 7 and 14.
Study Overview
Brief Summary
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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
Outcomes
Primary Outcomes
Azithromycin Ocular Conjunctiva Concentrations on Days 7 and 14.
Azithromycin Tear Concentrations on Day 7.
Secondary Outcomes
- Tolerance
Investigators
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