Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin) (Pazufloxacin)
Bacterial Conjunctivitis
About this trial
This is an interventional treatment trial for Bacterial Conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- Obtained from physician office visit.
- Diagnosis of bacterial conjunctivitis (signs and / or symptoms and / or culture).
- Informed Consent signed and dated (consent of the parents for minor patients).
Exclusion Criteria:
- absence of written informed consent.
- Women of childbearing age, without contraceptive use (oral contraceptive pill, contraceptive intrauterine device, contraceptive implant, patch or condom).
- Pregnant or breastfeeding women.
- Subjects that could not be evaluated partially or totally according to the protocol.
- Subjects with topical, systemic or intravenous medication with any type of antibiotic on the day of the baseline visit.
- Subjects with topical, systemic or intravenous medication with any type of medication that interferes decisively with the results of the study.
- Subjects with a hypersensitivity history to any component or analogues of the formulation product.
- Positive drug addiction (smoking, alcoholism, marijuana).
- Subjects with a history of participation in any clinical study in the last 40 days prior to their evaluation.
- incapacity to give informed consent owing to mental disorder or legal condition.
- Any major anomaly detected during the clinical examination, tests that could interfere with the performance of the study or with the efficacy and safety evaluations.
Sites / Locations
- Unidad Medica "Grupo Pediátrico"
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
PRO-157 BID (2 times per day)
PRO-157 TID (3 times per day)
PRO-157 QID (4 times per day)
Moxifloxacin (Vigamox®)
Gatifloxacin (Zymar®)
60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)
60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)
60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)
60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)
60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)