A Clinical trial to study the safety and efficacy of Loteprednol etabonate + Gatifloxacin in the treatment of post operative inflammation.

Evaluation of Safety and Efficacy of Loteprednol Etabonate + Gatifloxacin eye drops in the treatment of Post Operative Inflammatory conditions of the Anterior Segment of the Eye.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001085

Enrollment

100

Registered

2010-08-10

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

None listed

Interventions

Intervention1: Loteprednol Gatifloxacin Eye drops: 2 drops 3 times a day Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients of both the sexes, 18 years and above.

Exclusion criteria

Exclusion criteria: Pregnant women and lactating mothers. Presence of any other damage to eye/ nerve including physical damage. Hypersensitivity or intolerance to fluoroquinolones or any other component of the medication. Patients with serve/ uncontrolled renal, hepatic or endocrine abnormality. Patients with concomitant fungus, virus or tuberculous infections of the eye. Patients who have contracted more than 4 infections of the external eye with the duration of one of the infections being longer than 2 weeks during the 12 months prior to being considered for admission in to the trial.

Design outcomes

Primary

Measure	Time frame
AcceptabilityTimepoint: 10 days;Clinical efficacy-signs and symptomsTimepoint: 10 days;Global response to treatmentTimepoint: 10 days;Number of days treatment requiredTimepoint: Three days, seven days and ten days;Safety-adverse drug reactionTimepoint: 10 days;ToleranceTimepoint: 10 days	—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr Sushil Choubey

choubey_sushil@allergan.com+919901777116

Outcome results