Effectiveness Comparison Between the Drugs TOBRACORT® and TOBRADEX® in Reducing the Signs and Symptoms of Acute Bacterial Conjunctivitis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01227915
First received: October 15, 2010
Last updated: October 22, 2010
Last verified: October 2010
| Tracking Information | |
|---|---|
| First Received Date ICMJE | October 15, 2010 |
| Last Updated Date | October 22, 2010 |
| Start Date ICMJE | February 2011 |
| Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Effectiveness compared between drugs using the percentage of improvement (sustained response rate) at the end of treatment. [ Time Frame: 7 days of treatment ] [ Designated as safety issue: No ] 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. |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01227915 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
|
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Effectiveness Comparison Between the Drugs TOBRACORT® and TOBRADEX® in Reducing the Signs and Symptoms of Acute Bacterial Conjunctivitis |
| Official Title ICMJE | 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 |
| Brief Summary | 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. |
| Detailed Description |
|
| Study Type ICMJE | Interventional |
| Study Phase | Phase 3 |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Condition ICMJE | Acute Bacterial Conjunctivitis |
| Intervention ICMJE |
|
| Study Arm (s) |
|
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Not yet recruiting |
| Estimated Enrollment ICMJE | 70 |
| Completion Date | Not Provided |
| Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Not Provided |
| Location Countries ICMJE | Brazil |
| Administrative Information | |
| NCT Number ICMJE | NCT01227915 |
| Other Study ID Numbers ICMJE | TODUNI0610, Version 01 |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Alexandre Frederico, LAL Clínica Pesquisa e Desenvolvimento Ltda |
| Study Sponsor ICMJE | L.A.L Clinica Pesquisa e Desenvolvimento Ltda. |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | L.A.L Clinica Pesquisa e Desenvolvimento Ltda. |
| Verification Date | October 2010 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|