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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Bacterial Conjunctivitis |
Drug: Tobracort Drug: Tobradex |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Pinkeye
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Tobramycin
Tobramycin sulfate
U.S. FDA Resources
Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter established. [ 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.
- Statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during 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.
| Estimated Enrollment: | 70 |
| Study Start Date: | February 2011 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Test
tobramycin 0.3% + dexamethasone 1% - União Química Lab
|
Drug: Tobracort
tobramycin 0.3% + dexamethasone 1%
|
|
Active Comparator: Comparator
tobramycin 0.3% + dexamethasone 1% - Alcon Lab
|
Drug: Tobradex
tobramycin 0.3% + dexamethasone 1%
|
Detailed Description:
- Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter;
- Observation and statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Patients who agree with all study procedures and sign, by his own free will, IC;
- Adult patients, regardless of gender, ethnicity or social status, with good mental health;
- Patients who present at screening visit, a clinical picture of acute bacterial conjunctivitis diagnosed clinically.
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;
- Patients with a history or clinical diagnosis of other lesions that may affect the outcome, such as glaucoma, corneal ulcer or scars;
- Patients with known hypersensitivity to any component of the study drug;
- Concomitant use of ocular medication other than the study;
- Patients who have made use of systemic anti-inflammatory hormone in the 30 days preceding inclusion;
- Patients who have made use of systemic antibiotics in the 15 days preceding inclusion;
- Pregnant or lactating women;
- Being or having been treated for any type of conjunctivitis is less than 15 days, or have finished treatment at least 7 days
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227915
Locations
| Brazil | |
| LAL Clínica Pesquisa e Desenvolvimento Ltda | Not yet recruiting |
| Valinhos, São Paulo, Brazil | |
| Contact: Alexandre Frederico, doctor 55 19 3871-6399 alexandre@lalclinica.com.br | |
| Principal Investigator: Jose Roberto de Camargo, doctor | |
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
More Information
No publications provided
| Responsible Party: | Alexandre Frederico, LAL Clínica Pesquisa e Desenvolvimento Ltda |
| ClinicalTrials.gov Identifier: | NCT01227915 History of Changes |
| Other Study ID Numbers: | TODUNI0610, Version 01 |
| Study First Received: | October 15, 2010 |
| Last Updated: | October 22, 2010 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
|
SIGNS AND SYMPTOMS OF ACUTE BACTERIAL CONJUNCTIVITIS |
Additional relevant MeSH terms:
|
Conjunctivitis Conjunctivitis, Bacterial Signs and Symptoms Conjunctival Diseases Eye Diseases Eye Infections, Bacterial Bacterial Infections Eye Infections Infection Tobramycin Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Anti-Bacterial Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 17, 2013