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

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ClinicalTrials.gov Identifier: NCT01443442
Recruitment Status : Completed
First Posted : September 29, 2011
Last Update Posted : January 21, 2013
Sponsor:
Information provided by (Responsible Party):
Southern California College of Optometry

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.


Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: bepotastine besilate, 1.5% Drug: Loteprednol etabonate Phase 4

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : October 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arm Intervention/treatment
Experimental: bepotastine besilate
Two weeks treatment with 1.5% bepotastine besilate, twice per day
Drug: bepotastine besilate, 1.5%
Topical ocular aqueous formulation, oen drop per instillation, twice per day for 14 days
Other Name: Bepreve

Active Comparator: loteprednol etabonate
Two weeks treatment with 02 % loteprednol etabonate, four times per day
Drug: Loteprednol etabonate
Topical ocular aqueous formulation, one drop per instillation, four times per day for 14 days
Other Name: Alrex




Primary Outcome Measures :
  1. Change from Baseline in Ocular Itching [ Time Frame: Change from Baseline in Ocular Itching at 14 Days ]
    Ocular itching on a 0 - 4 scale in 0,5 scale unit increments

  2. Change from Baseline in Bulbar Redness [ Time Frame: Change from Baseline in Bulbar Redness at 14 Days ]
    Bulbar Redness, measured on a 0 - 4 scale using 0.5 unit increments



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443442


Locations
United States, California
Eye Car Center, Southern California college of Optometry
Fullerton, California, United States, 92831
Eye Care Center, Southern Caalifornia College of Optometry
Fullerton, California, United States, 92831
Sponsors and Collaborators
Southern California College of Optometry
Investigators
Principal Investigator: Judy Tong, OD Southern California College of Optometry

Responsible Party: Southern California College of Optometry
ClinicalTrials.gov Identifier: NCT01443442     History of Changes
Other Study ID Numbers: MAC-06-11
First Posted: September 29, 2011    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: January 2013

Keywords provided by Southern California College of Optometry:
Conjunctivitis
Allergic
Bepotastine besilate
Loteprednol etabonate

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Loteprednol Etabonate
Anti-Allergic Agents