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NCT01007253 · ClinicalTrials.gov registry record · Phase 4
Effect of Veramyst and Olopatadine 0.2% Opthalmic Solution on Allergy Symptoms
A Phase 4 study, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 4
- Development phase
- 21
- Enrollment target
NCT01007253: Completed Phase 4 study, sponsored by University of Chicago.
NCT01007253 is a Phase 4 study that has completed, run by University of Chicago. The registered enrollment target is 21 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01007253, a Phase 4 study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 21 participants
- Enrollment target
Study Summary
People who have hayfever or allergic rhinitis often complain about eye symptoms associated with their nasal symptoms. How people with hayfever develop eye symptoms is not clear. The purpose of this study is to better understand the generation of eye symptoms in patients with allergic rhinitis. We have previously shown that placing the substance that subjects are allergic to in their nose causes both nose and eye symptoms. This can be explain by a parasympathetic neurogenic reflex from the nose to the eye. Such a reflex would readily explain the tearing and watery eye symptoms, but does not explain the itch. In this study, we are going to address one possible explanation for the itch; does an axonal neurogenic reflex stimulate mast cells in the eye to release histamine, which then causes the itch? We will do this by placing an antihistamine drop in the eye and challenge the nose with allergen. We will also attempt to demonstrate that mast activation isn't effected by blocking the initiating of the reflex with a nasal steroid, as done in our previous study, and showing that the addition of an antihistamine does not add to the reduction of symptoms.
Primary Outcome
After treatment, each participant was subjected to a diluent (control) challenge in one eye and was asked to rate 2 eye symptoms (watery and itchy) according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The participant was then exposed to 3 doses of an antigen challenge and was asked to similarly rate severity of watery and itchy eye symptoms after each dose. Diluent challenge scores were subtracted from the scores recorded after each dose. This process was repeated in the other
Interventions
- DRUG fluticasone furoate (FF)
- DRUG PL nasal spray
- DRUG PL eye drops
- DRUG olopatadine (OLO)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-08 |
| Phase | Phase 4 |
What the finished NCT01007253 record still lists
NCT01007253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 4 interventions - of which fluticasone furoate (FF) is the first listed.
NCT01007253 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01007253 about?
NCT01007253 is a clinical study titled "Effect of Veramyst and Olopatadine 0.2% Opthalmic Solution on Allergy Symptoms". People who have hayfever or allergic rhinitis often complain about eye symptoms associated with their nasal symptoms. How people with hayfever develop eye symptoms is not clear. The purpose of this study is to better understand the generation of eye symptoms in patients with allergic rhinitis. We ha...
What is the current status of trial NCT01007253?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 21 participants. The study started on 2009-11. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01007253?
The interventions under investigation include: fluticasone furoate (FF) (DRUG), PL nasal spray (DRUG), PL eye drops (DRUG), olopatadine (OLO) (DRUG).
Who is sponsoring clinical trial NCT01007253?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01007253's enrollment target sits among peer trials
21 1742nd of 2000 higher than 248 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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