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The primary objective of this study is to demonstrate the efficacy of T1225 eye drops versus placebo eye drops on the global ocular discomfort (VAS).
Currently, topical antibiotic ointments are used for blepharitis. They provide prolonged contact time with the lid margin but with little penetration into eyelid tissue. Azithromycin eye drops may offer on advantage over these preparations because azithromycin achieves sustained high concentration in various ocular tissues including the lid margin.
Patients will be treated for 7 days (1 drop twice daily the first day following by one drop once daily for 6 days) following by a period of 2 weeks without treatment. This therapeutic scheme will be repeated two times.
Efficacy will be evaluated by change from baseline (Day 0) to Day 63 ± 3 Days of the global ocular discomfort evaluation (VAS).
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Azithromycin (T1225/Azyter), Povidone
Hôpital Gabriel Montpied
Not yet recruiting
Published on BioPortfolio: 2010-07-15T17:00:00-0400
To compare the ocular tolerance, safety and ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225.
To evaluate azithromycin tear concentrations after instillation of one drop of one of the three T1225 concentrations (0.5%, 1% and 1.5%) and to evaluate the ocular safety.
To assess in children the efficacy and safety of 2 dosing regimens of T1225 1.5% eye drops, in comparison to a reference product, single-dose oral azithromycin (AZM) 20 mg/kg, for the trea...
The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus placebo over a four-week treatment period.
The purpose of this study is to determine: - The prevalence of Demodex sp. in chronic blepharitis. - The efficacy of the treatment of topical Tree Tea Oil in chronic blepharitis fo...
to identify the role of laser scanning confocal microscopy (LSCM) in diagnostic and to assess the effectiveness of involutional blepharitis treatment.
To report the rates of postintravitreal injection (IVT) endophthalmitis with topical conjunctival application of various concentrations of povidone-iodine (PI), including no PI.
To determine the relationship between the components of the metabolic syndrome with the presence of blepharitis.
Demodex acari is an obligate ectoparasite, and it is usually located in the human hair follicles, eyelash roots, and sebaceous glands. The aim of this study was to investigate the presence of Demodex ...
Long-term Impact of Oral Azithromycin taken by Gambian women during Labour on Prevalence and Antibiotic Susceptibility of S. pneumoniae and S. aureus in their Infants: Follow up of a Randomized Clinical Trial.
Oral azithromycin given to women in labour decreases maternal and neonatal bacterial carriage but increases azithromycin resistant bacteria during at least 4 weeks following the intervention. We asses...
Inflammation of the eyelids.
A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis.
A polyvinyl polymer of variable molecular weight; used as suspending and dispersing agent and vehicle for pharmaceuticals; also used as blood volume expander.
An iodinated polyvinyl polymer used as topical antiseptic in surgery and for skin and mucous membrane infections, also as aerosol. The iodine may be radiolabeled for research purposes.
Preparations used as alternatives or supplements to hand washing with soap and water to destroy microorganisms and prevent transmission of pathogens. The active ingredient may be ETHANOL; 1-PROPANOL; or POVIDONE-IODINE in a gel, foam, or liquid solution.