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

NCT ID: NCT01443442

Last Updated: 2019-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-12-31

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

Conditions

Allergic Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bepreve

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

Group Type: ACTIVE_COMPARATOR

bepotastine besilate, 1.5%

Intervention Type: DRUG

Topical ocular aqueous formulation, oen drop per instillation, twice per day for 14 days

Alrex

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

Group Type: ACTIVE_COMPARATOR

Loteprednol etabonate

Intervention Type: DRUG

Topical ocular aqueous formulation, one drop per instillation, four times per day for 14 days

Interventions

bepotastine besilate, 1.5%

Topical ocular aqueous formulation, oen drop per instillation, twice per day for 14 days

Intervention Type: DRUG

Loteprednol etabonate

Topical ocular aqueous formulation, one drop per instillation, four times per day for 14 days

Intervention Type: DRUG

Other Intervention Names

Bepreve; Alrex

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southern California College of Optometry at Marshall B. Ketchum University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judy Tong, OD

Role: PRINCIPAL_INVESTIGATOR

Southern California College of Optometry at Marshall B. Ketchum University

Locations

Eye Car Center, Southern California college of Optometry

Fullerton, California, United States

Eye Care Center, Southern Caalifornia College of Optometry

Fullerton, California, United States

Countries

United States

Other Identifiers

MAC-06-11

Identifier Type: -

Identifier Source: org_study_id