UnknownPhase 3

Effectiveness Comparison Between the Drugs TOBRACORT® and TOBRADEX® in Reducing the Signs and Symptoms of Acute Bacterial Conjunctivitis

Brazil70 participantsStarted 2011-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effectiveness compared between drugs using the percentage of improvement (sustained response rate) at the end of treatment.

Timeframe: 7 days of treatment

Trial details

NCT IDNCT01227915

SponsorAzidus Brasil

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-02

View on ClinicalTrials.gov More Acute Bacterial Conjunctivitis trials