A Phase 3 interventional study of Tobracort and Tobradex in Acute Bacterial Conjunctivitis, sponsored by Azidus Brasil. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-10-25.
Sponsored by Azidus Brasil · Phase 3, Interventional, and Treatment
The primary objective of this study is to evaluate, through clinical parameters, the comparative efficacy between topical Tobracort ® (tobramycin 0.3% dexamethasone + 1% - Chemistry Lab Union) and TOBRADEX ® (tobramycin 0.3% dexamethasone + 1 % - Alcon Lab), using the percentage of improvement (sustained response rate) at the end of treatment.
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's planned enrollment of 70 is below the median of 261 across 36 interventional studies indexed under Conjunctivitis, Bacterial.
Browse Conjunctivitis, Bacterial studies →Azidus Brasil is the lead sponsor of 80 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients who agree with all study procedures and sign, by his own free will, IC;
Exclusion Criteria:
Patients with clinical diagnosis of conjunctivitis due to any process other than bacterial infection, such as infections by fungi, protozoa, viruses, or allergic conjunctivitis;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
tobramycin 0.3% + dexamethasone 1% - União Química Lab
Drug: Tobracort
tobramycin 0.3% + dexamethasone 1% - Alcon Lab
Drug: Tobradex
tobramycin 0.3% + dexamethasone 1%
tobramycin 0.3% + dexamethasone 1%
Effectiveness compared between drugs using the percentage of improvement (sustained response rate) at the end of treatment.
There will be a total of three returns after inclusion (0 day), and they are 1, 3 and 7 days after initiation of treatment.At the returns of 1 and 3 days, there will be a tolerance of +1 day, and the return of seven days, the tolerance will be ± 1 days. On each return, will be collected data on the efficacy and safety as defined in this protocol.
Time frame: 7 days of treatment
Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter established.
There will be a total of three returns after inclusion (0 day), and they are 1, 3 and 7 days after initiation of treatment.At the returns of 1 and 3 days, there will be a tolerance of +1 day, and the return of seven days, the tolerance will be ± 1 days. On each return, will be collected data on the efficacy and safety as defined in this protocol.
Time frame: 7 days of treatment.
Statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.
There will be a total of three returns after inclusion (0 day), and they are 1, 3 and 7 days after initiation of treatment.At the returns of 1 and 3 days, there will be a tolerance of +1 day, and the return of seven days, the tolerance will be ± 1 days. On each return, will be collected data on the efficacy and safety as defined in this protocol.
Time frame: 7 days of treatment.
This study is status unknown, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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