CompletedNCT01443442Updated Aug 6, 2019Results posted

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

A Phase 4 interventional study of bepotastine besilate, 1.5% and Loteprednol etabonate in Allergic Conjunctivitis, sponsored by Southern California College of Optometry at Marshall B. Ketchum University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-06.

Sponsored by Southern California College of Optometry at Marshall B. Ketchum University · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 23
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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 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

Conditions studied

Allergic Conjunctivitis

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Keywords

Conjunctivitis
Allergic
Bepotastine besilate
Loteprednol etabonate

In context

Conjunctivitis

361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.

This study's enrollment of 23 is below the median of 100 across 299 interventional studies indexed under Conjunctivitis.

Browse Conjunctivitis studies →

Lead sponsor

Southern California College of Optometry at Marshall B. Ketchum University is the lead sponsor of 19 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Investigator)
Enrollment: 23 participants (actual)

Study arms

Active comparator
Bepreve
1.5% bepotastine besilate, drops, twice per day, for two weeks
Drug: bepotastine besilate, 1.5%
Active comparator
Alrex
treatment with 0.2 % loteprednol etabonate, drops, four times per day
Drug: Loteprednol etabonate

Interventions

Drugbepotastine besilate, 1.5%
Topical ocular aqueous formulation, oen drop per instillation, twice per day for 14 days
Also known as: Bepreve
DrugLoteprednol etabonate
Topical ocular aqueous formulation, one drop per instillation, four times per day for 14 days
Also known as: Alrex

What researchers measure

Primary outcomes

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.
Time frame: Change from Baseline in Ocular Itching at 14 Days

Results

Posted Aug 6, 2019

Participant flow

Participant flow — Overall Study
Milestone	Bepreve	Alrex
Started	12	11
Completed	12	11
Not completed	0	0

Outcome measures

PrimaryChange 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.

Time frame:: Change from Baseline in Ocular Itching at 14 Days
Reported as:: Mean · units on a scale

Change From Baseline in Ocular Itching at 14 Days
units on a scale	Bepreve	Alrex
Change From Baseline in Ocular Itching at 14 Days	2.17 ± 0.53	1.82 ± 0.47

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Bepreve	—	0/12 (0%)	0/12 (0%)
Alrex	—	0/11 (0%)	0/11 (0%)

Baseline characteristics

Age, Customized
Age, Customized(years)	Bepreve	Alrex	Total
Mean	49.3 ± 16.3	53.0 ± 13.0	51.1 ± 2.6

Sex: Female, Male
Sex: Female, Male(Participants)	Bepreve	Alrex	Total
Female	8	7	15
Male	4	4	8

Region of Enrollment
Region of Enrollment(participants)	Bepreve	Alrex	Total
United States	12	11	23

Study locations

2 sites

Eye Car Center, Southern California college of Optometry
Fullerton, California 92831, United States
Eye Care Center, Southern Caalifornia College of Optometry
Fullerton, California 92831, United States

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01443442
Lead sponsor: Southern California College of Optometry at Marshall B. Ketchum University
Responsible party: Sponsor
First posted: Sep 29, 2011
Start date: Oct 2011
Primary completion: Sep 2012
Completion: Dec 2012
Results posted: Aug 6, 2019
Last update: Aug 6, 2019

Study contacts

Judy Tong, OD

principal investigator · Southern California College of Optometry at Marshall B. Ketchum University

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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