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Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis

Primary Purpose

Allergic Conjunctivitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bepotastine besilate, 1.5%
Loteprednol etabonate
Sponsored by
Southern California College of Optometry at Marshall B. Ketchum University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring Conjunctivitis, Allergic, Bepotastine besilate, Loteprednol etabonate

Eligibility Criteria

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

Inclusion Criteria:

  • Moderate to severe allergic subjects (≥ 2.5 on a 0.0 to 4.0 itching scale AND

    > grade 2.0 bulbar redness using validated (Efron) scale)

  • Must be able to understand and sign an informed consent form that has been approved by the Institutional Review Board (IRB).
  • Can comply with instillation of study drug
  • Must be able to comply with the visit schedule and other requirements of the study.

Exclusion Criteria:

  • Subjects who use daily wear (5-7 days / week, 6-16 hours/day)25 disposable soft hydrogel or silicone hydrogel contact lenses will be included in the study if they have been consistently wearing the same brand and have been using the same care solution for one month or longer. They will be asked to not wear their soft contact lenses to the eligibility visit (three days of no lens wear) and be willing to discontinue lens wear during the two weeks of the study because of the incompatibility of medicated eye drop instillation with contact lens wear and the potential confounding effect of contact lenses and care solutions.
  • Active inflammation of the cornea, iris, anterior chamber
  • Active or suspected herpetic eye disease (simplex, vaccinia, varicella)
  • Active or suspected mycobacterial or acanthamoeba infection
  • Active for suspected fungal disorders of the eye
  • Persistent and significant dry eye syndrome
  • Known allergy, contraindications or hypersensitivity to loteprednol, bepotastine, or its components
  • Pregnancy or breast-feeding
  • Use of topical eye drops, topical or systemic antihistamines, topical, nasal or systemic corticosteroids, immunosuppressive or immunomodulating agents, decongestants, aspirin, or non-steroidal antiinflammatory (NSAIDs) during the two weeks prior to the study.
  • Participation in any other study within 30 days of this study.

Sites / Locations

  • Eye Car Center, Southern California college of Optometry
  • Eye Care Center, Southern Caalifornia College of Optometry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bepreve

Alrex

Arm Description

1.5% bepotastine besilate, drops, twice per day, for two weeks

treatment with 0.2 % loteprednol etabonate, drops, four times per day

Outcomes

Primary Outcome Measures

Change From Baseline in Ocular Itching at 14 Days
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.

Secondary Outcome Measures

Full Information

First Posted
September 27, 2011
Last Updated
July 16, 2019
Sponsor
Southern California College of Optometry at Marshall B. Ketchum University
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1. Study Identification

Unique Protocol Identification Number
NCT01443442
Brief Title
Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis
Official Title
A Single-Center, Masked, Randomized Study Comparing Bepreve (Bepotastine Besilate) 1.5% - H1 Specific Antihistamine vs. Alrex (Loteprednol Etabonate) 0.2% - Corticosteroid in Subjects With Moderate to Severe Allergic Conjunctivitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southern California College of Optometry at Marshall B. Ketchum University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
Investigator and Study Center: Judy Tong, OD Eye Care Center Southern California College of Optometry Test Product, Dose and Mode of Administration: Bepreve (bepotastine besilate ophthalmic solution) 1.5% bid ou vs. Alrex (loteprednol etabonate ophthalmic suspension) 0.2% qid ou Study Title: A Single-Center, Masked, Randomized Study Comparing Bepreve (bepotastine besilate) 1.5% - H1 Specific Antihistamine vs. Alrex (loteprednol etabonate) 0.2% - Corticosteroid in Subjects with Moderate to Severe Allergic Conjunctivitis Primary Objective(s): The primary objective of this study is to compare 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 patients over the age of 18 years of age Study Design: Interventional, Randomized, Parallel Arm, Investigator Masked Study Population: Subjects over the age of 18 years of age with moderate to severe allergic conjunctivitis. Duration of Treatment: 14 days Efficacy Assessments: Itching, Bulbar conjunctival injection, Bulbar conjunctival chemosis Safety Assessments: N/A

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
Keywords
Conjunctivitis, Allergic, Bepotastine besilate, Loteprednol etabonate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bepreve
Arm Type
Active Comparator
Arm Description
1.5% bepotastine besilate, drops, twice per day, for two weeks
Arm Title
Alrex
Arm Type
Active Comparator
Arm Description
treatment with 0.2 % loteprednol etabonate, drops, four times per day
Intervention Type
Drug
Intervention Name(s)
bepotastine besilate, 1.5%
Other Intervention Name(s)
Bepreve
Intervention Description
Topical ocular aqueous formulation, oen drop per instillation, twice per day for 14 days
Intervention Type
Drug
Intervention Name(s)
Loteprednol etabonate
Other Intervention Name(s)
Alrex
Intervention Description
Topical ocular aqueous formulation, one drop per instillation, four times per day for 14 days
Primary Outcome Measure Information:
Title
Change From Baseline in Ocular Itching at 14 Days
Description
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.
Time Frame
Change from Baseline in Ocular Itching at 14 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Moderate to severe allergic subjects (≥ 2.5 on a 0.0 to 4.0 itching scale AND > grade 2.0 bulbar redness using validated (Efron) scale) Must be able to understand and sign an informed consent form that has been approved by the Institutional Review Board (IRB). Can comply with instillation of study drug Must be able to comply with the visit schedule and other requirements of the study. Exclusion Criteria: Subjects who use daily wear (5-7 days / week, 6-16 hours/day)25 disposable soft hydrogel or silicone hydrogel contact lenses will be included in the study if they have been consistently wearing the same brand and have been using the same care solution for one month or longer. They will be asked to not wear their soft contact lenses to the eligibility visit (three days of no lens wear) and be willing to discontinue lens wear during the two weeks of the study because of the incompatibility of medicated eye drop instillation with contact lens wear and the potential confounding effect of contact lenses and care solutions. Active inflammation of the cornea, iris, anterior chamber Active or suspected herpetic eye disease (simplex, vaccinia, varicella) Active or suspected mycobacterial or acanthamoeba infection Active for suspected fungal disorders of the eye Persistent and significant dry eye syndrome Known allergy, contraindications or hypersensitivity to loteprednol, bepotastine, or its components Pregnancy or breast-feeding Use of topical eye drops, topical or systemic antihistamines, topical, nasal or systemic corticosteroids, immunosuppressive or immunomodulating agents, decongestants, aspirin, or non-steroidal antiinflammatory (NSAIDs) during the two weeks prior to the study. Participation in any other study within 30 days of this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy Tong, OD
Organizational Affiliation
Southern California College of Optometry at Marshall B. Ketchum University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye Car Center, Southern California college of Optometry
City
Fullerton
State/Province
California
ZIP/Postal Code
92831
Country
United States
Facility Name
Eye Care Center, Southern Caalifornia College of Optometry
City
Fullerton
State/Province
California
ZIP/Postal Code
92831
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis

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