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

NCT01443442 | Completed Phase 4 Results

• 1 other identifier: MAC-06-11
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Allergic Conjunctivitis

Keywords

Conjunctivitis; Allergic; Bepotastine besilate; Loteprednol etabonate

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Ocular Itching at 14 Days

  Ocular Itching Scale. Scale is 0 - 4 in 0.5 scale unit increments. 0 equals no Itch. 4 equals most severe itch. No calculation details are necessary as the change is calculated as the latest time point minus the earliest time point.

  Change from Baseline in Ocular Itching at 14 Days

Study Arms (2)

Bepreve

ACTIVE COMPARATOR

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

Drug: bepotastine besilate, 1.5%

Alrex

ACTIVE COMPARATOR

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

Drug: Loteprednol etabonate

Interventions

bepotastine besilate, 1.5% DRUG

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

Also known as: Bepreve

Bepreve

Loteprednol etabonate DRUG

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

Also known as: Alrex

Alrex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southern California College of Optometry at Marshall B. Ketchum University: lead

Study Sites (2)

Eye Car Center, Southern California college of Optometry

Fullerton, California, 92831, United States

Location

Eye Care Center, Southern Caalifornia College of Optometry

Fullerton, California, 92831, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic; Conjunctivitis

Interventions

bepotastine besilate; Loteprednol Etabonate

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Jerry R. Paugh, OD, PhD
• Organization: SCCO at MBKU

jpaugh@ketchum.edu

714-449-7487

Study Officials

• Judy Tong, OD

  Southern California College of Optometry at Marshall B. Ketchum University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: September 29, 2011
• Study Start: October 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 6, 2019
• Results First Posted: August 6, 2019

Record last verified: 2019-07

Locations

US (2)