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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.
Instillation of artificial tears is standard treatment in dry eye syndrome and in patients experiencing dry eye symptoms when wearing contact lenses. Povidone K25 eye drops (povidone) is a...
To compare the efficacy of a dedicated eyelid cleanser and diluted baby shampoo in the management of blepharitis.
Identifying potentially treatable risk factors for the progression of keratoconus is of great importance. The purpose of this study was to determine the association between blepharitis and keratoconus...
to identify the role of laser scanning confocal microscopy (LSCM) in diagnostic and to assess the effectiveness of involutional blepharitis treatment.
This prospective, randomized, double-blind interventional case series was designed to evaluate the short-term efficacy of 0.03% tacrolimus ointment as a new therapeutic approach for refractory cases o...
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.