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NCT01443442 · ClinicalTrials.gov registry record · Phase 4
Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis
A Phase 4 study, sponsored by Southern California College of Optometry at Marshall B. Ketchum University.
- Completed
- Registry status
- Phase 4
- Development phase
- 23
- Enrollment target
NCT01443442: Completed Phase 4 study, sponsored by Southern California College of Optometry at Marshall B. Ketchum University.
NCT01443442 is a Phase 4 study that has completed, run by Southern California College of Optometry at Marshall B. Ketchum University. The registered enrollment target is 23 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
NCT01443442, a Phase 4 study, has completed, sponsored by Southern California College of Optometry at Marshall B. Ketchum University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 23 participants
- Enrollment target
Study Summary
Allergic conjunctivitis (AC) afflicts approximately 20% of the US population. Typically, patients manifest symptoms in the spring, summer and fall, when airborne allergens are at their peak. Patients may also be afflicted year-round, if sensitive to allergens such as dust mites or pet dander. Signs and symptoms of allergic conjunctivitis are conjunctival hyperemia, ocular itching, conjunctival and eyelid edema, papillary hypertrophy, tearing and burning. This is a randomized clinical study to evaluate the efficacy of Bepreve® (bepotastine besilate 1.5% ophthalmic solution) compared to Alrex® (loteprednol etabonate 0.2%) in the treatment of moderate to severe allergic conjunctivitis in patient over the age of 18 years. The study will be a two-week study with four visits. Ocular signs (eye redness( and symptoms (itching) will be monitored as outcome variables.
Primary Outcome
Ocular Itching Scale. Scale is 0 - 4 in 0.5 scale unit increments. 0 equals no Itch. 4 equals most severe itch. No calculation details are necessary as the change is calculated as the latest time point minus the earliest time point.
Interventions
- DRUG Loteprednol etabonate
- DRUG bepotastine besilate, 1.5%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2011-10 |
| Est. Completion | 2012-12 |
| Phase | Phase 4 |
What the finished NCT01443442 record still lists
NCT01443442 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 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 2 interventions - of which Loteprednol etabonate is the first listed.
NCT01443442 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01443442 about?
NCT01443442 is a clinical study titled "Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis". Allergic conjunctivitis (AC) afflicts approximately 20% of the US population. Typically, patients manifest symptoms in the spring, summer and fall, when airborne allergens are at their peak. Patients may also be afflicted year-round, if sensitive to allergens such as dust mites or pet dander. Signs ...
What is the current status of trial NCT01443442?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2011-10. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01443442?
The interventions under investigation include: Loteprednol etabonate (DRUG), bepotastine besilate, 1.5% (DRUG).
Who is sponsoring clinical trial NCT01443442?
This trial is sponsored by Southern California College of Optometry at Marshall B. Ketchum University, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01443442's enrollment target sits among peer trials
23 1725th of 2000 higher than 270 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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