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

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

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.