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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 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.

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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.

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

FieldValue
Enrollment Target 101 participants
Start Date 2010-04
Est. Completion 2010-08
Phase Phase 2

Sponsor

Bausch & Lomb Incorporated

174 total trials

What the Registry Record Tells You About NCT01107405

The ClinicalTrials.gov registry entry for NCT01107405 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 130-participant average among 20 other Allergic Conjunctivitis trials with a reported enrollment target (22% lower). The listed sponsor is Bausch & Lomb Incorporated, which has 174 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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