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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01227915
Other study ID # TODUNI0610
Secondary ID Version 01
Status Not yet recruiting
Phase Phase 3
First received October 15, 2010
Last updated October 22, 2010
Start date February 2011

Study information

Verified date October 2010
Source L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Contact n/a
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 70
Est. completion date
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Intervention

Drug:
Tobracort
tobramycin 0.3% + dexamethasone 1%
Tobradex
tobramycin 0.3% + dexamethasone 1%

Locations

Country Name City State
Brazil LAL Clínica Pesquisa e Desenvolvimento Ltda Valinhos São Paulo

Sponsors (1)

Lead Sponsor Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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. 7 days of treatment. No
Secondary 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. 7 days of treatment. No
See also
  Status Clinical Trial Phase
Completed NCT00348348 - A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis Phase 3
Completed NCT00347932 - A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis. Phase 3
Completed NCT05816070 - Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Bacterial Conjunctivitis Phase 2