Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: bepotastine besilate, 1.5%; Loteprednol etabonate
Intervention description: Topical ocular aqueous formulation, oen drop per instillation, twice per day for 14 days; Topical ocular aqueous formulation, one drop per instillation, four times per day for 14 days
Intervention MeSH terms: Loteprednol Etabonate; Bepotastine besilate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Conjunctivitis; Allergic; Bepotastine besilate; Loteprednol etabonate

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.
    

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.