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).

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% in patients with Bacterial conjunctivitis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000279

Enrollment

200

Registered

2010-03-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Bacterial conjunctivitis Health Condition 2: H108- Other conjunctivitis

Interventions

Intervention1: Besifloxacin ophthalmic suspension 0.6%: Instill 1 drop in both eyes 3 times daily for 5 days Control Intervention1: Moxifloxacin ophthalmic solution 0.5%: Instill 1 drop in both eyes 3

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.Timepoint: Day 0 and Day 5.;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.Timepoint: Day 0 and Day 5.;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.Timepoint: Day 0 and Day 5.;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.Timepoint: Day 0 and Day 5.	—

Measure

Time frame

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.Timepoint: Day 0 and Day 5.;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.Timepoint: Day 0 and Day 5.;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.Timepoint: Day 0 and Day 5.;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.Timepoint: Day 0 and Day 5.

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Secondary

Measure	Time frame
Global assessmentTimepoint: Day 5;Safety and tolerabilityTimepoint: Day 5	—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd, Advent

shaileshs@ajantapharma.com022-66062112

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026