Status:
COMPLETED
Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis
Lead Sponsor:
Southern California College of Optometry at Marshall B. Ketchum University
Conditions:
Allergic Conjunctivitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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 solutio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01443442
Start Date
October 1 2011
End Date
December 1 2012
Last Update
August 6 2019
Active Locations (2)
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1
Eye Car Center, Southern California college of Optometry
Fullerton, California, United States, 92831
2
Eye Care Center, Southern Caalifornia College of Optometry
Fullerton, California, United States, 92831