RANDOMIZED CLINICAL EVALUATION OF EFFECTIVENESS COMPARISON BETWEEN DRUGS OPHTHALMOLOGICAL TOBRACORT® (TOBRAMYCIN + DEXAMETHASONE - LAB. UNIÃO QUÍMICA)AND TOBRADEX® (TOBRAMYCIN + DEXAMETHASONE - LAB. ALCON) IN REDUCING THE SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS
Sponsor study identifier
Secondary identifiers
interventional
70
1 country
1
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
Not reported
Date not reportedThe 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 15, 2010
Actual (reported)October 25, 2010
Actual (reported)February 2011
Date type not reportedThis date has not been verified as actual or estimated.
February 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
7 days of treatment
Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter established.
7 days of treatment.
Statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.
7 days of treatment.
tobramycin 0.3% + dexamethasone 1% - União Química Lab
tobramycin 0.3% + dexamethasone 1% - Alcon Lab
tobramycin 0.3% + dexamethasone 1%
tobramycin 0.3% + dexamethasone 1%
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
LAL Clínica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, Brazil
First Submitted
October 15, 2010
First Posted
October 25, 2010
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2011
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 25, 2010
Record last verified: 2010-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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