A study to compare efficacy and safety of topical alcaftadine versus topical olopatadine in patients with allergic conjunctivits
Phase 4
- Conditions
- Health Condition 1: H109- Unspecified conjunctivitis
- Registration Number
- CTRI/2024/03/064161
- Lead Sponsor
- eeraj Rajdan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patient aged 5-20 years of age with history of allergic conjunctivitis presenting to OPD will be enrolled
Exclusion Criteria
Subjects undergone any ocular surgical intervention within three months
Patients on steroid therapy, immunotherapeutic agents
Patients using other topical eye drops (ocular lubricants)
Patients used any investigational medication within one month of the study
Patients with known hypersensitivity to Olopatadine & Alcaftadine
Pregnant and lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in total severity score at subsequent visit will be taken as primary outcome of drug. Efficacy will be measured as mean difference between severity score at two different visits for all patients in both treatment groupsTimepoint: first day, 2nd week, 4th week
- Secondary Outcome Measures
Name Time Method Safety will be assessed by adverse events throughout the study. Adverse drug reaction (ADR) will be noted and will be assessed as per WHO UMC Causality assessment scale and Modified Hartwig Siegel’s severity scaleTimepoint: first day, 2nd week, 4th week