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Antihistamine
Ocular Allergy Treatment Practical Impact Trial ((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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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