Allergic ConjunctivitisPhase 4NCT01443442
Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis
A Phase 4 study testing bepotastine besilate, 1.5% and Loteprednol etabonate in people with Allergic Conjunctivitis, run by Southern California College of Optometry at Marshall B. Ketchum University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- bepotastine besilate, 1.5% and Loteprednol etabonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2011to Dec 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Eye Car Center, Southern California college of Optometry
Fullerton, California, 92831
Eye Care Center, Southern Caalifornia College of Optometry
Fullerton, California, 92831
About this study
Official 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
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
- Allergic Conjunctivitis
- Being tested
- bepotastine besilate, 1.5%, Loteprednol etabonate
- Keywords
- Conjunctivitis, Allergic, Bepotastine besilate, Loteprednol etabonate
- Medical subject headings
- Conjunctivitis, Allergic, Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bepotastine besilate, 1.5%Drug
Also called Bepreve
Topical ocular aqueous formulation, oen drop per instillation, twice per day for 14 days
Loteprednol etabonateDrug
Also called Alrex
Topical ocular aqueous formulation, one drop per instillation, four times per day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Bepreve | Active comparator | 1.5% bepotastine besilate, drops, twice per day, for two weeks Receives: Drug: bepotastine besilate, 1.5% |
| Alrex | Active comparator | treatment with 0.2 % loteprednol etabonate, drops, four times per day Receives: Drug: Loteprednol etabonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline in Ocular Itching at 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allergic ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern California College of Optometry at Marshall B. Ketchum University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judy Tong, OD, Principal investigator, Southern California College of Optometry at Marshall B. Ketchum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443442
- Sponsor's protocol ID
- MAC-06-11
- Status last verified
- Jul 2019
- First submitted
- 27 Sep 2011
- Last updated
- 6 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01443442
- Acronym / sponsor ID
- MAC-06-11
- Conditions
- Allergic Conjunctivitis
- Keywords
- Conjunctivitis, Allergic, Bepotastine besilate, Loteprednol etabonate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Southern California College of Optometry at Marshall B. Ketchum UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Sep 2011 (estimated)
- Results
- Posted 6 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bepreve | Active comparator | Drug: bepotastine besilate, 1.5%1.5% bepotastine besilate, drops, twice per day, for two weeks |
| Alrex | Active comparator | Drug: Loteprednol etabonatetreatment with 0.2 % loteprednol etabonate, drops, four times per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bepotastine besilate, 1.5%Also: BepreveTopical ocular aqueous formulation, oen drop per instillation, twice per day for 14 days | Drug | Bepreve |
| Loteprednol etabonateAlso: AlrexTopical ocular aqueous formulation, one drop per instillation, four times per day for 14 days | Drug | Alrex |
Primary outcome
Change From Baseline in Ocular Itching at 14 Days
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judy Tong, OD principal investigator
Southern California College of Optometry at Marshall B. Ketchum University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bepotastine besilate, 1.5% and Loteprednol etabonate in people with Allergic Conjunctivitis, run by Southern California College of Optometry at Marshall B. Ketchum University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Ocular Itching at 14 Days (time frame: Change from Baseline in Ocular Itching at 14 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.