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: Other conjunctivitis,

• Registration Number: CTRI/2010/091/000279
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

This study is a comparative, randomized, double blind, multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Besifloxacin ophthalmic suspension 0.6% Vs Moxifloxacin ophthalmic solution 0.5% (Reference Drug) in 200 patients with Bacterial conjunctivitis in india. Date of first enrollment will be 27 April 2010. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

The primary outcome measures will be slit lamp biomicroscopy, tear culture examination, ophthalmoscopic examination, redness of the eyes, eye pain, blurred vision, sensitivity to light, burning or itching of the eye, a scratchy feeling in the eye and discharge at day 0 and 5. Secondary outcome will be safety and tolerability and global assessment at day 5.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-27
• Last Update Posted: 2018-11-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.
• Patients providing written informed consent to participate in the trial.

Exclusion Criteria

• Patients < 18 & > 60 years.2. Pregnant or nursing females3.
• 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
The primary outcome measures will be slit lamp biomicroscopy, tear culture examination, ophthalmoscopic examination, redness of the eyes, eye pain, blurred vision, sensitivity to light, burning or itching of the eye, a scratchy feeling in the eye and discharge.	Day 0 and Day 5.

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability	Day 5
Global assessment	Day 5

Trial Locations

Locations (4)

Kamala Eye & Maternity Home; 🇮🇳 Thane, MAHARASHTRA, India

Murlidhar Nursing and Maternity Home; 🇮🇳 Thane, MAHARASHTRA, India

Nakshatra Netralaya; 🇮🇳 Latur, MAHARASHTRA, India

Rani Masaheb Rotary Eye Hospital and Research Center; 🇮🇳 Dhule, MAHARASHTRA, India

Kamala Eye & Maternity Home

🇮🇳Thane, MAHARASHTRA, India

Dr Rajendra Jain

Principal investigator

09920678238

drrajendrajain@gmail.com