Phase 4
N=23
Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis
Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT01443442 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Change From Baseline in Ocular Itching at 14 Days — 2.17; 1.82 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- bepotastine besilate, 1.5% (Drug); Loteprednol etabonate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Southern California College of Optometry at Marshall B. Ketchum University
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Ocular Itching at 14 Days |
2.17; 1.82 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01443442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.