A clinical Trial in patients with Bacterial conjunctivitis. Clinical trial is to study efficacy, safety and tolerability of Besifloxacin ophthalmic suspension in comparison to Moxifloxacin ophthalmic solution (reference product).
Phase 3
Completed
- Conditions
- Health Condition 1: null- Bacterial conjunctivitisHealth Condition 2: H108- Other conjunctivitis
- Registration Number
- CTRI/2010/091/000279
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1. Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.
2. Patients providing written informed consent to participate in the trial.
Exclusion Criteria
1. Patients < 18 & > 60 years.
2. Pregnant or nursing females
3. Known hypersensitivity to fluroquinolones or to any of the study ingredients.
4. Use of any antibiotic within 72 hours of treatment.
5. Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications.
6. Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method