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A study to compare efficacy and safety of topical alcaftadine versus topical olopatadine in patients with allergic conjunctivits

Comparative study to evaluate efficacy and safety of topical alcaftadine 0.25% versus topical olopatadine 0.2% eye drops in patients with allergic conjunctivits in a tertiary care teaching hospital, Haldwani - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064161
Enrollment
240
Registered
2024-03-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Health Condition 1: H109- Unspecified conjunctivitis

Interventions

Intervention1: Topical Olopatadine: 0.2% eye drop will be given once daily for 4 weeks Control Intervention1: Topical Alcaftadine: 0.25% eye drop will be given once daily for 4 weeks

Sponsors

Neeraj Rajdan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient aged 5-20 years of age with history of allergic conjunctivitis presenting to OPD will be enrolled

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactBhavana Srivastava

Government Medical College,Haldwani

drsbhavana@gmail.com7895782824

Outcome results

None listed

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