the clinical study was canceled by the sponsor due to logistics and programming
PRO-143
Study to Evaluate the Safety and Tolerability of Pro-143 Ophthalmic Solution in Healthy Volunteers.
Sponsor study identifier
Secondary identifiers
interventional
0
1 country
1
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study to evaluate the safety and tolerability of PRO-143 solution ophthalmic in healthy volunteers.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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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.
February 22, 2012
Actual (reported)November 2013
Date type not reportedThis date has not been verified as actual or estimated.
February 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 5, 2018
Actual (reported)Conjunctival bulbar hyperemia
Conjunctival hyperemia is defined as the simplest reaction of the conjunctiva to a stimulus, a red appearance secondary to the vasodilation of the conjunctival vessels of variable intensity. He will graduate using the Efron scale. 0 Normal , 1 Very slight, 2 Mild, 3 Moderate, 4 Severe.
10 days
Number of Participants with adverse events
he evaluation of adverse events requires a questioning conducted by the principal investigator and the appropriate exploratory techniques for its detection. the number of adverse events per study group will be considered for the analysis
10 days
Intraocular pressure (IOP)
10 days
Visual ability (VA)
10 days
Eye comfort index (ICO)
10 days
PRO-143 Ophthalmic Solution applied four times per day (c/6 hours) during 10 days.
PRO-143 Ophthalmic Solution applied four times per day (C/6 hours) during 10 days.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Independent Clinical Research Center
Guadalajara, Jalisco, 44100, Mexico
José F Alaniz-De La O, MD
Independent Clinical Research Center
Laura R Saucedo-Rodíguez, MD
Independent Clinical Research Center
Leopoldo M Baiza-Durán, MD
Clinical Research Department. Laboratorios Sophia SA de CV
0 participants (actual enrollment reported by the registry).
First Submitted
February 22, 2012
First Posted
October 5, 2018
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
Efficacy of the Ophthalmic Pazufloxacin 0.6% for Bacterial Conjunctivitis, Compared to Gatifloxacin 0.3%.
Contact the study team to confirm eligibility.
Primary Completion
February 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 10, 2018
Record last verified: 2018-10
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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