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Antihistamine

Alcaftadine for Hay Fever ((OAT-PIT) Trial)

Phase 4
Waitlist Available
Led By Jayesh Kanuga, MD
Research Sponsored by Starx Research Center, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing alcaftadine eye drops on patients with eye allergies to see if it works better than other treatments. Alcaftadine helps by stopping the substances that cause allergy symptoms like itching and redness. Alcaftadine 0.25% ophthalmic solution has been shown to be well tolerated and effective in relieving ocular itching in subjects with seasonal or perennial allergic conjunctivitis.

Eligible Conditions
  • Hay Fever
  • Allergic Eye

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AlcaftadineExperimental Treatment1 Intervention
subject on any ocular allergy ophthalmic treatment or no treatment will be started on Alcaftadine 0.25%(study drug)- 1 drop each eye daily for 1-2 weeks

Find a Location

Who is running the clinical trial?

Starx Research Center, LLCLead Sponsor
Jayesh Kanuga, MDPrincipal InvestigatorStarx Research Center, LLC
~4 spots leftby Nov 2025
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