Allergic ConjunctivitisPhase 4NCT01337557
Use of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% for Allergic Conjunctivitis and Contact Lenses
A Phase 4 study testing Bepotastine in people with Allergic Conjunctivitis, run by Hom, Milton M., OD, FAAO.
Trial summary
The purpose of this study is to assess if BEPREVE (bepotastine besilate ophthalmic solution) 1.5% will have an effect on contact lens wear in patients with contact lens intolerance due to allergic conjunctivitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- Bepotastine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Nov 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History of allergic conjunctivitis
- History of contact lens intolerance
- Between the ages of 18 and over inclusive.
- Males or females
- Patient is in generally good \& stable overall health.
- Patient likely to comply with study guidelines \& study visits. Informed consent signed.
Show all 10Show fewer
- Are willing/able to return for all required study visits.
- Are willing/able to follow instructions from the study investigator and his/her staff.
- If a woman capable of becoming pregnant, agree to have urine pregnancy testing performed at screening (must be negative) and agree to use a medically acceptable form of birth control throughout the study duration and for at least one week prior to and after completion of the study. Women considered capable of becoming pregnant include all females who have experienced menarche and who have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).
- Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.
Who cannot join
- Corneal refractive surgery within 6 months of this study.
- Current use of Restasis
- Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
- Pregnant or lactating women.
- Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
- Systemic or injected corticosteroids (including oral, parenteral, intravenous, rectal) 30 days;
Show all 15Show fewer
- Nasal or inhaled or ocular corticosteroids 14 days;
- Nasal or inhaled ipratropium bromide (or atropine), inhaled nedocromil, or nasal, inhaled, or ophthalmic sodium cromolyn 14 days;
- Agents with antihistaminic/anticholinergic activity (e.g. antidepressants, antipsychotics) 14 days;
- Leukotriene pathway modifiers (Accolate, Singulair, Zyflo) 10 days;
- Ocular anti-allergy medications including lodoxamide (Alomide), olopatadine (Patanol/Pataday), emedastine difumarate (Emadine), epinastine (Elestat), levocabastine (Livostin) 7 days;
- Non-steroidal anti-inflammatory ophthalmics including bromfenac (Xibrom), ketorolac (Acular/Acuvail), nepafenac (Nevanac), flurbiprofen (Ocufen), suprofen (Profenal), diclofenac (Voltaren) 7 days;
- OTC ophthalmic decongestant, antihistamine, or decongestant/antihistamine combinations 3 days;
- Other anticholinergic agents 3 days
- Immunotherapy injection 1 day.
About this study
The purpose of this study is to assess if BEPREVE (bepotastine besilate ophthalmic solution) 1.5% will have an effect on contact lens wear in patients with contact lens intolerance due to allergic conjunctivitis.
- Conditions
- Allergic Conjunctivitis
- Being tested
- Bepotastine
- Keywords
- Allergic conjunctivitis
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BepotastineDrug
Also called Bepreve
1.5% bid
| Study group | Role | What they receive |
|---|---|---|
| Bepotastine | Experimental | Not described Receives: Drug: Bepotastine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire
Contact lens comfort and wearing times (measured in hours)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hom, Milton M., OD, FAAO
- Collaborators
- Bausch & Lomb Incorporated
- Investigators
- Milton M Hom, OD FAAO, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337557
- Sponsor's protocol ID
- MAC-03-11
- Status last verified
- Apr 2011
- First submitted
- 14 Apr 2011
- Last updated
- 19 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% for Allergic Conjunctivitis and Contact Lenses
- ClinicalTrials.gov ID
- NCT01337557
- Acronym / sponsor ID
- MAC-03-11
- Conditions
- Allergic Conjunctivitis
- Keywords
- Allergic conjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hom, Milton M., OD, FAAO
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- May 2011
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 19 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess if BEPREVE (bepotastine besilate ophthalmic solution) 1.5% will have an effect on contact lens wear in patients with contact lens intolerance due to allergic conjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bepotastine | Experimental | Drug: Bepotastine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- History of allergic conjunctivitis
- History of contact lens intolerance
- Between the ages of 18 and over inclusive.
- Males or females
- Patient is in generally good \& stable overall health.
Key exclusion criteria (15 listed)
- Corneal refractive surgery within 6 months of this study.
- Current use of Restasis
- Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
- Pregnant or lactating women.
- Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
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 |
|---|---|---|
| BepotastineAlso: Bepreve1.5% bid | Drug | Bepotastine |
Primary outcome
Questionnaire
Time frame: 8 weeks
Contact lens comfort and wearing times (measured in hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2011.
Related trials for Allergic Conjunctivitis
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy
Allergic Conjunctivitis
Recruiting
Daydrop® Triple Action for Allergic Eye Symptoms
Allergic Conjunctivitis of Both Eyes
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
RecruitingObservational study
Treatment of Ocular Surface Inflammations
Ocular Surface Allergy, Conjunctivitis, Allergic
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.
Milton M Hom, OD FAAO principal investigator
Private Practice
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bepotastine in people with Allergic Conjunctivitis, run by Hom, Milton M., OD, FAAO.
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 10 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Questionnaire (time frame: 8 weeks). 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 19 Apr 2011.