Back to results

Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge

Primary Purpose

Allergic Conjunctivitis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Loteprednol etabonate base (QD)

Loteprednol etabonate base (BID)

Loteprednol etabonate base (QID)

Loteprednol etabonate suspension

Vehicle of loteprednol etabonate

About this trial

This is an interventional prevention trial for Allergic Conjunctivitis

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
Calculated best-corrected visual acuity of 0.70 logMAR or better in each eye as measured using the ETDRS chart.
Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
Positive bilateral CAC reaction in 1 out of 3 time points for the initial and re-challenge at visit 2.

Exclusion Criteria:

Known contraindications or sensitivities to the study medication or its components.
Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
Use of disallowed medications during the period indicated prior to study enrollment or during the study.

Sites / Locations

Bausch & Lomb

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Loteprednol etabonate base (QD)

Loteprednol etabonate base (BID)

Loteprednol etabonate base (QID)

Loteprednol etabonate suspension (QID)

Vehicle of loteprednol etabonate

Arm Description

Loteprednol etabonate ophthalmic base dosed once/day.

Loteprednol etabonate ophthalmic base dosed two times/day

Loteprednol etabonate ophthalmic base dosed four times/day.

Loteprednol etabonate ophthalmic suspension dosed four times/day

Vehicle of loteprednol etabonate, dosed either QD, BID, or QID

Outcomes

Primary Outcome Measures

Ocular Itching

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.

Conjunctival Redness

Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.

Secondary Outcome Measures

Ocular Itching

Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.

Conjunctival Redness

Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.

Ocular Itching

Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.

Conjunctival Redness

Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.

Full Information

NCT ID

NCT01107405

First Posted

April 15, 2010

Last Updated

February 14, 2012

Sponsor

Bausch & Lomb Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01107405

Brief Title

Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge

Official Title

Efficacy of Loteprednol Etabonate Ophthalmic Base Compared to Loteprednol Etabonate Ophthalmic Suspension vs Placebo in a Modified Conjunctival Allergen Challenge(CAC) Model

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Conjunctivitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

101 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Loteprednol etabonate base (QD)

Arm Type

Active Comparator

Arm Description

Loteprednol etabonate ophthalmic base dosed once/day.

Arm Title

Loteprednol etabonate base (BID)

Arm Type

Active Comparator

Arm Description

Loteprednol etabonate ophthalmic base dosed two times/day

Arm Title

Loteprednol etabonate base (QID)

Arm Type

Active Comparator

Arm Description

Loteprednol etabonate ophthalmic base dosed four times/day.

Arm Title

Loteprednol etabonate suspension (QID)

Arm Type

Active Comparator

Arm Description

Loteprednol etabonate ophthalmic suspension dosed four times/day

Arm Title

Vehicle of loteprednol etabonate

Arm Type

Placebo Comparator

Arm Description

Vehicle of loteprednol etabonate, dosed either QD, BID, or QID

Intervention Type

Drug

Intervention Name(s)

Loteprednol etabonate base (QD)

Intervention Description

Loteprednol Etabonate ophthalmic base once daily dosing for 2 weeks

Intervention Type

Drug

Intervention Name(s)

Loteprednol etabonate base (BID)

Intervention Description

Loteprednol etabonate ophthalmic base BID dosing for 2 weeks

Intervention Type

Drug

Intervention Name(s)

Loteprednol etabonate base (QID)

Intervention Description

Loteprednol Etabonate ophthalmic base four times/day dosing for 2 week

Intervention Type

Drug

Intervention Name(s)

Loteprednol etabonate suspension

Intervention Description

Loteprednol etabonate ophthalmic suspension dosed four times daily for 2 weeks.

Intervention Type

Drug

Intervention Name(s)

Vehicle of loteprednol etabonate

Intervention Description

Vehicle of loteprednol etabonate ophthalmic dosed once, twice or four times daily for 2 weeks.

Primary Outcome Measure Information:

Title

Ocular Itching

Description

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.

Time Frame

Visit 4 (8 hr re-challenge)

Title

Conjunctival Redness

Description

Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.

Time Frame

Visit 4 (8 hr re-challenge)

Secondary Outcome Measure Information:

Title

Ocular Itching

Description

Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.

Time Frame

Visit 3 (initial challenge)

Title

Conjunctival Redness

Description

Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.

Time Frame

Visit 3 (initial challenge)

Title

Ocular Itching

Description

Evaluated by the subject at 3, 5 and 7 min post-challenge on a scale of 0-4 where 0=no itching and 4=incapacitating itch.

Time Frame

Visit 4 (initial challenge)

Title

Conjunctival Redness

Description

Evaluated by investigator at 7, 15 and 20 minutes post challenge on a scale of 0-4 where 0= no redness and 4=extremely severe redness.

Time Frame

Visit 4 (initial challenge)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months. Calculated best-corrected visual acuity of 0.70 logMAR or better in each eye as measured using the ETDRS chart. Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes of instillation of the last titration of allergen at visit 1. Positive bilateral CAC reaction in 1 out of 3 time points for the initial and re-challenge at visit 2. Exclusion Criteria: Known contraindications or sensitivities to the study medication or its components. Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters. Use of disallowed medications during the period indicated prior to study enrollment or during the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tuyen Ong, MD

Organizational Affiliation

Bausch & Lomb Incorporated

Official's Role

Study Director

Facility Information:

Facility Name

Bausch & Lomb

City

Rochester

State/Province

New York

ZIP/Postal Code

14603

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge

We'll reach out to this number within 24 hrs