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NCT01107405 · ClinicalTrials.gov registry record · Phase 2
Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge
A Phase 2 study of Allergic Conjunctivitis, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 101
- Enrollment target
- 1
- Study location
NCT01107405: Completed Phase 2 study of Allergic Conjunctivitis, sponsored by Bausch & Lomb Incorporated.
NCT01107405 is a Phase 2 study of Allergic Conjunctivitis that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 101 participants, below the 130-participant average among 20 other Allergic Conjunctivitis trials with a reported enrollment target (22% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01107405, a Phase 2 study of Allergic Conjunctivitis, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 101 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the efficacy of loteprednol etabonate ophthalmic base, compared to loteprednol etabonate ophthalmic suspension, and vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in a modified Conjunctival Allergen Challenge model and in an environmental model during pollen season. Comparisons will be made following 2 weeks of dosing.
Primary Outcome
Evaluated by subject at 3, 5, and 7 min post challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.
Conditions Studied
Interventions
- DRUG Loteprednol etabonate base (QD)
- DRUG Loteprednol etabonate base (BID)
- DRUG Loteprednol etabonate base (QID)
- DRUG Loteprednol etabonate suspension
- DRUG Vehicle of loteprednol etabonate
Study Locations (1)
New York
- Bausch & Lomb - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2010-04 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
What the finished NCT01107405 record still lists
NCT01107405 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 130-participant average among 20 other Allergic Conjunctivitis trials with a reported enrollment target (22% lower).
The record links to 1 condition, with Allergic Conjunctivitis appearing as the primary indexed condition, and to 5 interventions - of which Loteprednol etabonate base (QD) is the first listed.
NCT01107405 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01107405 about?
NCT01107405 is a clinical study titled "Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge". The purpose of this study is to evaluate the efficacy of loteprednol etabonate ophthalmic base, compared to loteprednol etabonate ophthalmic suspension, and vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in a modified Conjunctival Allergen Challenge model and in an en...
What is the current status of trial NCT01107405?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2010-04. Estimated completion is 2010-08.
What conditions does trial NCT01107405 study?
This clinical trial studies the following conditions: Allergic Conjunctivitis.
What interventions are being tested in trial NCT01107405?
The interventions under investigation include: Loteprednol etabonate base (QD) (DRUG), Loteprednol etabonate base (BID) (DRUG), Loteprednol etabonate base (QID) (DRUG), Loteprednol etabonate suspension (DRUG), Vehicle of loteprednol etabonate (DRUG).
Who is sponsoring clinical trial NCT01107405?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01107405 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01107405's enrollment target sits among peer trials
101 10th of 20 higher than 10 of 20 other Allergic Conjunctivitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Allergic Conjunctivitis 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.
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