Allergic ConjunctivitisPhase 3NCT00586664

Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis

A Phase 3 study testing Bepreve (bepotastine besilate ophthalmic solution) 1.5% and Bepotastine Besilate Ophthalmic Solution 1.0% in people with Allergic Conjunctivitis, run by Bausch & Lomb Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Efficacy and safety study of bepotastine besilate ophthalmic solution in allergic conjunctivitis Read more about this study

Who is it for?: Ages 10 years and older
Conditions the study is for: Allergic Conjunctivitis
What is being tested?: Bepreve (bepotastine besilate ophthalmic solution) 1.5% and Bepotastine Besilate Ophthalmic Solution 1.0%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 130 participants
Where: 1 siteUnited States
Study dates: Oct 2007to Jun 2008
Phase: Phase 3
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 10 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subjects must be at least 10 years of age

Who cannot join

No active ocular disease

Trial locations and contacts

1 site in 1 country.

United States1 site

ISTA Pharmaceuticals, Inc.
Irvine, California, 92618

Other trials in United States

About this study

Efficacy and safety study of bepotastine besilate ophthalmic solution in allergic conjunctivitis

Conditions: Allergic Conjunctivitis
Being tested: Bepreve (bepotastine besilate ophthalmic solution) 1.5%, placebo comparator, Bepotastine Besilate Ophthalmic Solution 1.0%
Medical subject headings: Conjunctivitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bepreve (bepotastine besilate ophthalmic solution) 1.5%Drug
sterile ophthalmic solution
placebo comparatorDrug
sterile ophthalmic solution
Bepotastine Besilate Ophthalmic Solution 1.0%Drug
sterile ophthalmic solution

Study groups in NCT00586664
Study group	Role	What they receive
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	Experimental	Not described Receives: Drug: Bepreve (bepotastine besilate ophthalmic solution) 1.5%
Bepotastine Besilate Ophthalmic Solution 1.0%	Experimental	Not described Receives: Drug: Bepotastine Besilate Ophthalmic Solution 1.0%
Placebo	Placebo comparator	Not described Receives: Drug: placebo comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

Ocular Itching
Ocular Itching score: 0=None; 0.5=Intermittent tickle sensation possibly localized in the corner of the eye; 1.0=Intermittent tickle sensation involving more than the corner of the eye; 1.5=Intermittent all-over tickling sensation; 2.0=Mild continuous itch (can be localized) without desire to rub; 2.5=Moderate, diffuse continuous itch with desire to rub; 3.0=Severe itch with desire to rub; 3.5=Severe itch improved with minimal rubbing; 4.0=Incapacitating itch with irresistible urge to rub
Measured: 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Conjunctival Redness
Conjunctival Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade
Measured: 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model

Secondary outcomes (11)

Ciliary Redness
Ciliary Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade
Measured: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Episcleral Redness
Episcleral Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade
Measured: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Chemosis
Chemosis score: 0 = None; 1.0 = Mild-Detectable only by slit lamp beam; definite separation of conjunctiva from sclera; 2.0 = Moderate-Visible in normal room light; more diffuse edema; 3.0 = Severe-Conjunctival billowing at the limbus; very diffuse and noticeable; 4.0 = Extremely severe-Overall ballooning of conjunctiva
Measured: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Eyelid Swelling
Eyelid Swelling score: 0 = None; 1.0 = Mild-Detectable swelling of lower and/or upper lid; 2.0 = Moderate-Definite swelling of lower and/or upper lid; 3.0 = Severe-Swelling of lower and/or upper lid to the point that there is a decrease in the space between your upper and lower lids
Measured: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Rhinorrhea (Runny Nose)
Rhinorrhea score: 0 = None; 1.0 = Mild-Sensation of nasal mucus flowing down nasal passage; no discharge present; 2.0 = Moderate-May be associated with post-nasal drip; nasal mucus flow more pronounced; will need to blow nose soon; 3.0 = Moderate/Severe-Nasal mucus discharge requiring occasional wiping with Kleenex; 4.0 = Severe-Uncontrolled nasal discharge; requiring frequent wiping and blowing nose
Measured: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Nasal Pruritus (Itchy Nose)
Nasal Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub
Measured: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Ear or Palate Pruritus (Itchy Ear or Palate)
Ear or Palate Pruritus score: 0 = None; 1.0 = Mild-An intermittent tickle sensation; 2.0 = Moderate-A mild continuous itch; 3.0 = Moderate/Severe-A severe itch with desire to rub; 4.0 = Severe-Incapacitating itch with an irresistible urge to rub
Measured: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Nasal Congestion
Nasal Congestion score: 0 = None-Breathes freely; 1.0 = Mild-Breathes with difficulty; 2.0 = Moderate-One nostril partially blocked; 3.0 = Moderate/Severe-Both nostrils partially blocked or one nostril completely blocked and the other nostril partially blocked; 4.0 = Severe-Both nostrils completely blocked
Measured: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Total Non-Ocular Composite Symptom
Total Non-Ocular Composite Symptom score (Composite of Rhinorrhea, Nasal Pruritus, Ear or Palate Pruritus, and Nasal Congestion): 0 = None; 1.0 = Mild; 2.0 = Moderate; 3.0 = Moderate/Severe; 4.0 = Severe
Measured: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Tearing
Percent of Eyes with Tearing as measured 7, 15 \& 20 minutes post-CAC. Scored as absent or present
Measured: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Ocular Mucus Discharge
Percent of Eyes with Ocular Mucus Discharge as measured 7, 15 \& 20 minutes post-CAC.
Scored as absent or present
Measured: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Jun 2008

First posted4 Jan 2008 (estimated)
Study startOct 2007
Primary completionJun 2008
Study completionJun 2008

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.
Publications (2)Papers the sponsor has linked to this study.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00586664
Sponsor's protocol ID: CL-S&E-0409071-P
Status last verified: Feb 2013
First submitted: 21 Dec 2007
Last updated: 8 Feb 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Meier EJ, Torkildsen GL, Gow JA, McNamara TR, Gomes PJ, Williams JI; Bepotastine Besilate Ophthalmic Solutions Study Group. Integrated phase III trials of bepotastine besilate ophthalmic solution 1.5% for ocular itching associated with allergic conjunctivitis. Allergy Asthma Proc. 2012 May-Jun;33(3):265-74. doi: 10.2500/aap.2012.33.3570.
PubMed 22991696
Macejko TT, Bergmann MT, Williams JI, Gow JA, Gomes PJ, McNamara TR, Abelson MB; Bepotastine Besilate Ophthalmic Solutions Clinical Study Group. Multicenter clinical evaluation of bepotastine besilate ophthalmic solutions 1.0% and 1.5% to treat allergic conjunctivitis. Am J Ophthalmol. 2010 Jul;150(1):122-127.e5. doi: 10.1016/j.ajo.2010.02.007. Epub 2010 May 20.
PubMed 20488431

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Allergic Conjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis
ClinicalTrials.gov ID: NCT00586664
Acronym / sponsor ID: CL-S&E-0409071-P
Conditions: Allergic Conjunctivitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 4 Jan 2008 (estimated)
Results: Posted 26 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Efficacy and safety study of bepotastine besilate ophthalmic solution in allergic conjunctivitis

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	Experimental	Drug: Bepreve (bepotastine besilate ophthalmic solution) 1.5%
Bepotastine Besilate Ophthalmic Solution 1.0%	Experimental	Drug: Bepotastine Besilate Ophthalmic Solution 1.0%
Placebo	Placebo comparator	Drug: placebo comparator

Who may qualify

Ages: 10 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Subjects must be at least 10 years of age

Key exclusion criteria (1 listed)

No active ocular disease

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
Bepreve (bepotastine besilate ophthalmic solution) 1.5%sterile ophthalmic solution	Drug	Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
placebo comparatorsterile ophthalmic solution	Drug	Placebo
Bepotastine Besilate Ophthalmic Solution 1.0%sterile ophthalmic solution	Drug	Bepotastine Besilate Ophthalmic Solution 1.0%

Primary outcome

Ocular Itching
Time frame: 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Ocular Itching score: 0=None; 0.5=Intermittent tickle sensation possibly localized in the corner of the eye; 1.0=Intermittent tickle sensation involving more than the corner of the eye; 1.5=Intermittent all-over tickling sensation; 2.0=Mild continuous itch (can be localized) without desire to rub; 2.5=Moderate, diffuse continuous itch with desire to rub; 3.0=Severe itch with desire to rub; 3.5=Severe itch improved with minimal rubbing; 4.0=Incapacitating itch with irresistible urge to rub
Conjunctival Redness
Time frame: 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Conjunctival Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade

11 secondary outcomes

Ciliary Redness
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Episcleral Redness
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Chemosis
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Eyelid Swelling
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Rhinorrhea (Runny Nose)
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Nasal Pruritus (Itchy Nose)
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Ear or Palate Pruritus (Itchy Ear or Palate)
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Nasal Congestion
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Total Non-Ocular Composite Symptom
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Tearing
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Ocular Mucus Discharge
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model

Results and safety

Results posted to the registry on 26 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	43	38
Placebo	43	36
Bepotastine Besilate Ophthalmic Solution 1.0%	44	43

Primary outcome: Ocular Itching

Time frame: 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model. Mean (Standard Deviation). Unit: Units on a scale

Measure	Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% n = 43	Placebo n = 43	Bepotastine Besilate Ophthalmic Solution 1.0% n = 44
15 Minutes post-dose: 3 minute post CAC	0.4 (0.6)	1.9 (1.0)	0.4 (0.7)
15 Minutes post-dose: 5 minute post CAC	0.5 (0.6)	2.1 (1.1)	0.6 (0.7)
15 Minutes post-dose: 7 minute post CAC	0.5 (0.6)	1.9 (1.2)	0.6 (0.7)
8 Hours post-dose: 3 minute post CAC	0.9 (0.9)	2.2 (1.0)	1.0 (0.8)
8 Hours post-dose: 5 minute post CAC	1.0 (0.8)	2.3 (1.1)	1.0 (0.7)
8 Hours post-dose: 7 minute post CAC	0.9 (0.8)	2.1 (1.1)	0.9 (0.7)
16 Hours post-dose: 3 minute post CAC	1.2 (0.8)	1.8 (1.0)	1.3 (0.8)
16 Hours post-dose: 5 minute post CAC	1.4 (1.0)	2.2 (1.1)	1.4 (0.8)

Primary outcome: Conjunctival Redness

Time frame: 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model. Mean (Standard Deviation). Unit: Units on a scale

Measure	Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% n = 43	Placebo n = 43	Bepotastine Besilate Ophthalmic Solution 1.0% n = 44
15 Minutes post-dose: 7 minute post CAC	1.4 (0.7)	1.9 (0.6)	1.3 (0.7)
15 Minutes post-dose: 15 minute post CAC	1.6 (0.8)	2.0 (0.6)	1.5 (0.8)
15 Minutes post-dose: 20 minute post CAC	1.7 (0.8)	1.9 (0.7)	1.6 (0.7)
8 Hours post-dose: 7 minute post CAC	1.3 (0.7)	1.7 (0.7)	1.3 (0.7)
8 Hours post-dose: 15 minute post CAC	1.5 (0.8)	1.9 (0.6)	1.6 (0.6)
8 Hours post-dose: 20 minute post CAC	1.6 (0.8)	1.9 (0.7)	1.6 (0.7)
16 Hours post-dose: 7 minute post CAC	1.8 (0.7)	1.9 (0.6)	1.5 (0.8)
16 Hours post-dose: 15 minute post CAC	1.9 (0.9)	2.0 (0.7)	1.6 (0.8)

11 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	0 of 43 (0%)	3 of 43 (7%)	Not reported
Placebo	0 of 43 (0%)	3 of 43 (7%)	Not reported
Bepotastine Besilate Ophthalmic Solution 1.0%	0 of 44 (0%)	5 of 44 (11.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22991696Meier EJ, Torkildsen GL, Gow JA, McNamara TR, Gomes PJ, Williams JI; Bepotastine Besilate Ophthalmic Solutions Study Group. Integrated phase III trials of bepotastine besilate ophthalmic solution 1.5% for ocular itching associated with allergic conjunctivitis. Allergy Asthma Proc. 2012 May-Jun;33(3):265-74. doi: 10.2500/aap.2012.33.3570.
Derived from this study: PubMed 20488431Macejko TT, Bergmann MT, Williams JI, Gow JA, Gomes PJ, McNamara TR, Abelson MB; Bepotastine Besilate Ophthalmic Solutions Clinical Study Group. Multicenter clinical evaluation of bepotastine besilate ophthalmic solutions 1.0% and 1.5% to treat allergic conjunctivitis. Am J Ophthalmol. 2010 Jul;150(1):122-127.e5. doi: 10.1016/j.ajo.2010.02.007. Epub 2010 May 20.

Related trials for Allergic Conjunctivitis

RecruitingPhase 3
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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.

Tim McNamara, PharmD study director

ISTA Pharmaceuticals, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 1 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 8 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 26 Mar 2012). 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?

Ocular Itching (time frame: 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00586664, which also lists 2 linked publications.

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 8 Feb 2013.