Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis...
Bacterial ConjunctivitisA randomized, double blind, phase II multicenter trial with the objective of assess the safety and efficacy of the PRO-157 ophthalmic solution in three different dosing regimens, versus Moxifloxacin, versus Gatifloxacin in patients with bacterial conjunctivitis. Number of participants: 300 eyes, 60 per group. Criteria for evaluation: Measurements of effectiveness: Main efficacy criterion It will be determined as effective if there is a reduction in number or species of bacterial flora by comparing the basal culture against the final culture among the five different patient groups. Reduction or absence of infection with the clinical evaluation through signs and symptoms. Safety Measurements: it will be determined by visual acuity and adverse events Patients recruited will be treated for 7, for protocol purpose, the infected eye (s) will be taken into account at the time of baseline, however the study medication and procedures will be applied and performed in both eyes to protect the healthy eye. The study is divided into the following evaluation periods: Visit 1 baseline (day 1), visit 2 (day 3), final visit (day 8) and a telephone call (day 23) for the evaluation of adverse events. Subjects will be allocated to any of the following regimen dosages: PRO-157 1 drop 2 times daily PRO-157 1 drop 3 times daily PRO-157 1 drop 4 times daily Moxifloxacin 1 drop 3 times daily Gatifloxacin 1 drop 3 times daily. All regimen dosage will have a duration of 7 days. An artificial tear preservative free (Lagricel Ofteno®) will also be applied 15 minutes before instillation of study drug, during study period. Data Analysis: The data will be analyzed by Intention to Treat (ITT) and per Protocol (PP) in which each of the variables is described, the ITT population will be constituted by all subjects recruited who have received at least one dose of the study, the PP population will be the subset of ITT composed of all subjects without any major deviation from the protocol and the bivariate analysis will be performed in this group. Continuous quantitative variables are expressed and presented by measures of central tendency and dispersion (mean, standard deviation and ranges). Qualitative nominal and ordinal variables are presented by means of frequencies and proportions. The level of significance was an alpha of 0.05 or less.
A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis
Bacterial ConjunctivitisThe study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis
Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for Bacterial...
Bacterial ConjunctivitisThe aim of the study is to evaluate the clinical and microbiological efficacies of three times daily administration of levofloxacin 0,5% eye drops as compared to the more frequent dosing (up to 8 times a day during the first 2 days and up to 4 times a day during the next 3 days) in patients with bacterial conjunctivitis.
A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis...
Bacterial ConjunctivitisThis is a 7 day study to evaluate the safety and efficacy of topical gatifloxacin ophthalmic solution for the treatment of bacterial conjunctivitis in subjects from birth to 31 days of age
A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis....
Acute Bacterial ConjunctivitisEvaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.
A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis...
Acute Bacterial ConjunctivitisThis is a study to investigate a novel drug candidate for the treatment of bacterial conjunctivitis.
An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% ((VIGAMOX®) Versus...
Bacterial ConjunctivitisThe purpose of this study is to evaluate Moxifloxacin 0.5% relative to Ofloxacin 0.3% in the treatment of bacterial conjunctivitis in Chinese patients.
Systemic Pharmacokinetics of BOL-303224-A
ConjunctivitisBacterialThis is a multi-center, open-label, single dose/multiple dose, pharmacokinetic study in participants with bacterial conjunctivitis. The purpose of this study is to determine the extent of systemic exposure to BOL-303224-A following single and multiple topical administration of BOL-303224-A in participants with suspected bacterial conjunctivitis.
Antibiotic Steroid Combination Compared With Individual Administration in the in the Treatment of...
Ocular InflammationInfection Associated Blepharitis3 moreTo evaluate the efficacy and safety of fixed combination of azithromycin 1.5% + 0.5% Loteprednol eye drops for the treatment of ocular inflammation and infection associated bacterial blepharitis and / or keratitis and / or conjunctivitis compared with the individual administration of azithromycin 1.5% and 0.5% Loteprednol (separately).
Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for Treatment of Bacterial...
Bacterial ConjunctivitisTo assess safety and efficacy of AL-15469A 0.5% /AL-6515 0.3% Ophthalmic Suspension for treatment of bacterial conjunctivitis