CompletedNCT00424398Updated Feb 15, 2013Results posted

Evaluation of the Onset and Duration of Action of Bepotastine Besilate Ophthalmic Solution in Acute Allergic Conjunctivitis

A Phase 2/3 interventional study of Bepreve and Placebo in Conjunctivitis, Allergic, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2013-02-15.

Sponsored by Bausch & Lomb Incorporated (part of Bausch Health Companies Inc.) · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 107
Allocation: Randomized
Ages: 10 Years and older
Sex: All

Study summary

The purpose of this study is to evaluate whether bepotastine besilate ophthalmic solution is effective in the treatment of acute allergic conjunctivitis

Conditions studied

Conjunctivitis, Allergic

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Conjunctivitis, Allergic 231

In context

Conjunctivitis, Allergic

231 studies on the registry are indexed under Conjunctivitis, Allergic; 19 are open to participants now.

This study's enrollment of 107 is above the median of 85 across 192 interventional studies indexed under Conjunctivitis, Allergic.

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Lead sponsor

Bausch & Lomb Incorporated is the lead sponsor of 223 studies on the registry; 5 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 41 (80%) have results posted.

First submitted before Bausch & Lomb Incorporated became part of Bausch Health Companies Inc..

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

Who can participate

Ages eligible: 10 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

At least 10 years of age \& either sex, any race
Willing and able to follow all instructions and attend all study visits
Positive history of ocular allergies

Exclusion criteria

Exclusion Criteria:

Have planned surgery during trial period
Female currently pregnant, planning a pregnancy, or lactating

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 107 participants (actual)

Study arms

Experimental
Bepreve
Bepotastine Besilate Ophthalmic Solution 1.5%
Drug: Bepreve
Placebo comparator
Placebo
sterile ophthalmic solution
Drug: Placebo
Experimental
Bepotastine Besilate
sterile ophthalmic solution 1.0%
Drug: Bepotastine Besilate

Interventions

DrugBepreve
sterile ophthalmic solution
DrugPlacebo
sterile ophthalmic solution
DrugBepotastine Besilate
sterile ophthalmic solution

What researchers measure

Primary outcomes

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
Time frame: 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
Time frame: 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model

Secondary outcomes

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
Time frame: 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
Time frame: 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
Time frame: 15 Minutes, 8 Hours & s6 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen challenge (CAC) Model
Tearing
Percent of Eyes with Tearing. Scored as absent or present
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Ocular Mucus Discharge
Percent of Eyes with Ocular Mucus Discharge. Scored as absent or present
Time frame: 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
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Total Nasal Symptom
Total Nasal 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
Time frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model

Results

Posted Mar 26, 2012

Participant flow

Participant flow — Overall Study
Milestone	Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	Placebo	Bepotastine Besilate Ophthalmic Solution 1.0%
Started	35	36	36
Completed	32	35	36
Not completed	3	1	0
Withdrew: Withdrawal by subject	2	1	0
Withdrew: Subject met exclusion criteria	1	0	0

Outcome measures

PrimaryOcular 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

Time frame:: 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Reported as:: Mean · Units on a scale

Ocular Itching
Units on a scale	Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	Placebo	Bepotastine Besilate Ophthalmic Solution 1.0%
15 Minutes post-dose: 3 Minutes post CAC	0.5 ± 0.8	1.9 ± 0.8	0.6 ± 0.7
15 Minutes post-dose: 5 Minutes post CAC	0.8 ± 0.9	2.1 ± 0.8	0.7 ± 0.8
15 Minutes post-dose: 7 Minutes post CAC	0.7 ± 0.9	2.0 ± 0.7	0.7 ± 0.8
8 Hours post-dose: 3 Minutes post CAC	0.8 ± 0.9	2.0 ± 0.7	1.2 ± 0.8
8 Hours post-dose: 5 Minutes post CAC	0.9 ± 1.0	2.3 ± 0.7	1.3 ± 0.8
8 Hours post-dose: 7 Minutes post CAC	0.9 ± 1.0	2.2 ± 0.8	1.3 ± 0.8
16 Hours post-dose: 3 Minutes post CAC	1.3 ± 1.0	2.1 ± 0.9	1.4 ± 0.7
16 Hours post-dose: 5 Minutes post CAC	1.5 ± 1.1	2.4 ± 0.8	1.6 ± 0.9
16 Hours post-dose: 7 Minutes post CAC	1.5 ± 1.0	2.3 ± 0.8	1.4 ± 1.0

PrimaryConjunctival 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

Time frame:: 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Reported as:: Mean · Units on a scale

Conjunctival Redness
Units on a scale	Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	Placebo	Bepotastine Besilate Ophthalmic Solution 1.0%
15 Minutes post-dose: 7 Minutes post CAC	1.4 ± 0.8	1.9 ± 0.6	1.1 ± 0.7
15 Minutes post-dose: 15 Minutes post CAC	1.7 ± 0.8	2.1 ± 0.6	1.5 ± 0.7
15 Minutes post-dose: 20 Minutes post CAC	1.6 ± 0.8	2.0 ± 0.6	1.4 ± 0.7
8 Hours post-dose: 7 Minutes post CAC	1.3 ± 0.7	1.7 ± 0.7	1.3 ± 0.6
8 Hours post-dose: 15 Minutes post CAC	1.5 ± 0.8	1.9 ± 0.6	1.6 ± 0.6
8 Hours post-dose: 20 Minutes post CAC	1.6 ± 0.8	1.9 ± 0.7	1.6 ± 0.7
16 Hours post-dose: 7 Minutes post CAC	1.7 ± 0.5	1.8 ± 0.6	1.4 ± 0.6
16 Hours post-dose: 15 Minutes post CAC	1.9 ± 0.6	1.8 ± 0.6	1.5 ± 0.7
16 Hours post-dose: 20 minutes post CAC	1.8 ± 0.6	1.7 ± 0.6	1.5 ± 0.7

SecondaryCiliary 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

Time frame:: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Reported as:: Mean · Units on a scale

Ciliary Redness
Units on a scale	Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	Placebo	Bepotastine Besilate Ophthalmic Solution 1.0%
15 Minutes post-dose: 7 Minute post CAC	1.2 ± 0.9	1.7 ± 0.6	0.9 ± 0.7
15 Minutes post-dose: 15 Minute post CAC	1.5 ± 0.9	1.9 ± 0.6	1.3 ± 0.8
15 Minutes post-dose: 20 Minute post CAC	1.6 ± 0.8	1.8 ± 0.7	1.3 ± 0.8
8 Hours post-dose: 7 Minute post CAC	1.2 ± 0.8	1.5 ± 0.7	1.2 ± 0.7
8 Hours post-dose: 15 Minute post CAC	1.5 ± 0.9	1.7 ± 0.7	1.5 ± 0.7
8 Hours post-dose: 20 Minute post CAC	1.4 ± 0.9	1.7 ± 0.7	1.4 ± 0.8
16 Hours post-dose: 7 Minute post CAC	1.6 ± 0.7	1.7 ± 0.6	1.3 ± 0.7
16 Hours post-dose: 15 Minute post CAC	1.9 ± 0.7	1.9 ± 0.6	1.5 ± 0.7
16 Hours post-dose: 20 Minute post CAC	1.7 ± 0.7	1.8 ± 0.7	1.4 ± 0.8

SecondaryEpiscleral 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

Time frame:: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Reported as:: Mean · Units on a scale

Episcleral Redness
Units on a scale	Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	Placebo	Bepotastine Besilate Ophthalmic Solution 1.0%
15 Minutes post-dose: 7 Minutes post CAC	1.3 ± 0.8	1.9 ± 0.6	1.1 ± 0.7
15 Minutes post-dose: 15 Minutes post CAC	1.6 ± 0.8	2.1 ± 0.6	1.5 ± 0.7
15 Minutes post-dose: 20 Minutes post CAC	1.6 ± 0.8	2.0 ± 0.7	1.4 ± 0.7
8 Hours post-dose: 7 Minutes post CAC	1.4 ± 0.7	1.7 ± 0.7	1.4 ± 0.6
8 Hours post-dose: 15 Minutes post CAC	1.6 ± 0.8	1.9 ± 0.6	1.7 ± 0.6
8 Hours post-dose: 20 Minutes post CAC	1.6 ± 0.8	1.9 ± 0.7	1.6 ± 0.7
16 Hours post-dose: 7 Minutes post CAC	1.8 ± 0.5	2.0 ± 0.5	1.4 ± 0.7
16 Hours post-dose: 15 Minutes post CAC	1.9 ± 0.7	2.0 ± 0.5	1.6 ± 0.7
16 Hours post-cose: 20 Minutes post CAC	1.9 ± 0.6	1.9 ± 0.6	1.5 ± 0.8

SecondaryChemosis

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

Time frame:: 15 Minutes, 8 Hours & s6 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Reported as:: Mean · Units on a scale

Chemosis
Units on a scale	Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	Placebo	Bepotastine Besilate Ophthalmic Solution 1.0%
15 Minutes post-dose: 7 Minutes post CAC	0.4 ± 0.3	0.7 ± 0.5	0.4 ± 0.3
15 Minutes post-dose: 15 Minutes post CAC	0.6 ± 0.5	0.9 ± 0.6	0.5 ± 0.3
15 Minutes post-dose: 20 Minutes post CAC	0.5 ± 0.3	0.8 ± 0.6	0.5 ± 0.3
8 Hours post-dose: 7 Minutes post CAC	0.5 ± 0.5	0.7 ± 0.5	0.5 ± 0.4
8 Hours post-dose: 15 Minutes post CAC	0.8 ± 0.7	0.9 ± 0.6	0.7 ± 0.4
8 Hours psot-dose: 20 Minutes post CAC	0.8 ± 0.7	0.9 ± 0.6	0.8 ± 0.4
16 Hours post-dose: 7 Minutes post CAC	0.7 ± 0.5	0.9 ± 0.4	0.6 ± 0.4
16 Hours post-dose: 15 Minutes post CAC	0.9 ± 0.5	1.1 ± 0.5	0.8 ± 0.4
16 Hours post-dose: 20 Minutes post CAC	0.9 ± 0.6	1.1 ± 0.6	0.8 ± 0.5

SecondaryRhinorrhea (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

Time frame:: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Reported as:: Mean · Units on a scale

Rhinorrhea (Runny Nose)
Units on a scale	Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	Placebo	Bepotastine Besilate Ophthalmic Solution 1.0%
15 Minutes post-dose: 7 Minutes post CAC	0.4 ± 0.8	0.9 ± 1.0	0.1 ± 0.3
15 Minutes post-dose: 15 Minutes post CAC	0.5 ± 0.9	1.1 ± 1.0	0.2 ± 0.6
15 Minutes post-dose: 20 Minutes post CAC	0.4 ± 0.8	0.9 ± 1.1	0.3 ± 0.6
8 Hours post-dose: 7 Minutes post CAC	0.2 ± 0.5	0.9 ± 1.0	0.3 ± 0.7
8 Hours post-dose: 15 Minutes post CAC	0.3 ± 0.6	1.5 ± 1.2	0.5 ± 0.8
8 Hours post-dose: 20 Minutes post CAC	0.3 ± 0.6	1.3 ± 1.3	0.4 ± 0.7
16 Hours post-dose: 7 Minutes post CAC	0.4 ± 0.7	1.0 ± 1.0	0.4 ± 0.8
16 Hours post-dose: 15 Minutes post CAC	0.6 ± 0.8	1.4 ± 1.1	0.8 ± 0.9
16 Hours post-dose: 20 Minutes post CAC	0.7 ± 0.9	1.2 ± 1.2	0.8 ± 1.0

SecondaryNasal 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

Time frame:: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Reported as:: Mean · Units on a scale

Nasal Pruritus (Itchy Nose)
Units on a scale	Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	Placebo	Bepotastine Besilate Ophthalmic Solution 1.0%
15 Minutes post-dose: 7 Minutes post CAC	0.3 ± 0.7	0.7 ± 0.8	0.1 ± 0.3
15 Minutes post-dose: 15 Minutes post CAC	0.2 ± 0.6	0.9 ± 0.8	0.2 ± 0.5
15 Minutes post-dose: 20 Minutes post CAC	0.2 ± 0.6	0.6 ± 0.8	0.3 ± 0.6
8 Hours post-dose: 7 Minutes post CAC	0.1 ± 0.4	0.6 ± 0.9	0.3 ± 0.7
8 Hours post-dose: 15 Minutes post CAC	0.2 ± 0.5	0.9 ± 1.1	0.3 ± 0.6
8 Hours post-dose: 20 Minutes post CAC	0.3 ± 0.6	0.8 ± 1.1	0.3 ± 0.6
16 Hours post-dose: 7 Minutes post CAC	0.5 ± 0.7	0.8 ± 1.0	0.3 ± 0.6
16 Hours post-dose: 15 Minutes post CAC	0.5 ± 0.9	0.9 ± 1.1	0.4 ± 0.6
16 Hours post-dose: 20 Minutes post CAC	0.5 ± 0.9	0.8 ± 1.1	0.4 ± 0.7

SecondaryEar 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

Time frame:: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Reported as:: Mean · Units on a scale

Ear or Palate Pruritus (Itchy Ear or Palate)
Units on a scale	Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	Placebo	Bepotastine Besilate Ophthalmic Solution 1.0%
15 Minutes post-dose: 7 Minutes post CAC	0.3 ± 0.7	0.6 ± 0.9	0.1 ± 0.2
15 Minutes post-dose: 15 Minutes post CAC	0.6 ± 0.9	0.9 ± 1.0	0.2 ± 0.5
15 Minutes post-dose: 20 Minutes post CAC	0.6 ± 0.9	0.9 ± 1.0	0.3 ± 0.6
8 Hours post-dose: 7 Minutes post CAC	0.2 ± 0.5	0.6 ± 0.9	0.4 ± 0.8
8 Hours post-dose: 15 Minutes post CAC	0.4 ± 0.9	1.2 ± 1.2	0.4 ± 0.8
8 Hours post-dose: 20 Minutes post CAC	0.5 ± 0.8	0.9 ± 1.1	0.5 ± 0.9
16 Hours post-dose: 7 Minutes post CAC	0.5 ± 0.7	0.6 ± 0.9	0.3 ± 0.8
16 Hours post-dose: 15 Minutes post CAC	0.8 ± 1.0	1.0 ± 1.2	0.8 ± 1.2
16 Hours post-dose: 20 Minutes post CAC	0.8 ± 1.0	0.9 ± 1.2	0.8 ± 1.1

SecondaryNasal 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

Time frame:: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen challenge (CAC) Model
Reported as:: Mean · Units on a scale

Nasal Congestion
Units on a scale	Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	Placebo	Bepotastine Besilate Ophthalmic Solution 1.0%
15 Minutes post-dose: 7 Minutes post CAC	0.5 ± 1.0	0.9 ± 1.0	0.2 ± 0.4
15 Minutes post-dose: 15 Minutes post CAC	0.4 ± 0.9	1.1 ± 1.2	0.3 ± 0.6
15 Minutes post-dose: 20 Minutes post CAC	0.4 ± 0.9	1.2 ± 1.1	0.3 ± 0.5
8 Hours post-dose: 7 Minutes post CAC	0.2 ± 0.5	0.9 ± 1.0	0.3 ± 0.6
8 Hours post-dose: 15 Minutes post CAC	0.4 ± 0.8	1.2 ± 1.2	0.4 ± 0.7
8 Hours post-dose: 20 Minutes post CAC	0.4 ± 0.8	1.1 ± 1.2	0.4 ± 0.7
16 Hours post-dose: 7 Minutes post CAC	0.4 ± 0.7	1.0 ± 1.0	0.4 ± 0.8
16 Hours post-dose: 15 Minutes post CAC	0.7 ± 1.0	1.3 ± 1.1	0.8 ± 1.0
16 Hours post-dose: 20 Minutes post CAC	0.7 ± 1.0	1.2 ± 1.2	0.8 ± 1.0

SecondaryTearing

Percent of Eyes with Tearing. Scored as absent or present

Time frame:: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Reported as:: Number · Percent of Eyes with Tearing Present

Tearing
Percent of Eyes with Tearing Present	Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	Placebo	Bepotastine Besilate Ophthalmic Solution 1.0%
15 Minutes post-dose: 7 Minutes post CAC	14.3	43.1	6.9
15 Minutes post-dose: 15 Minutes post CAC	17.1	34.7	9.7
15 Minutes post-dose: 20 Minutes post CAC	17.1	38.9	11.1
8 Hours post-dose: 7 Minutes post CAC	12.9	50.0	13.9
8 Hours post-dose: 15 Minutes post CAC	14.3	56.9	16.7
8 Hours post-dose: 20 Minutes post CAC	12.9	40.3	15.3
16 Hours post-dose: 7 Minutes post CAC	11.4	43.1	23.6
16 Hours post-dose: 15 Minutes post CAC	15.7	44.4	19.4
16 Hours post-dose: 20 Minutes post CAC	15.7	34.7	23.6

SecondaryOcular Mucus Discharge

Percent of Eyes with Ocular Mucus Discharge. Scored as absent or present

Time frame:: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Reported as:: Number · Percent of Eyes with OMD Present

Ocular Mucus Discharge
Percent of Eyes with OMD Present	Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	Placebo	Bepotastine Besilate Ophthalmic Solution 1.0%
15 Minutes post-dose: 7 Minutes post CAC	0.0	1.4	0.0
15 Minutes post-dose: 15 Minutes post CAC	2.9	0.0	0.0
15 Minutes post-dose: 20 Minutes post CAC	2.9	0.0	0.0
8 Hours post-dose: 7 Minutes post CAC	0.0	1.4	1.4
8 Hours post-dose: 15 Minutes post CAC	0.0	2.8	1.4
8 Hours post-dose: 20 Minutes post CAC	0.0	2.8	0.0
16 Hours post-dose: 7 Minutes post CAC	0.0	2.8	0.0
16 Hours post-dose: 15 Minutes post CAC	0.0	5.6	0.0
16 Hours post-dose: 20 Minutes post CAC	0.0	5.6	0.0

SecondaryEyelid 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

Time frame:: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Reported as:: Mean · Units on a scale

Eyelid Swelling
Units on a scale	Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	Placebo	Bepotastine Besilate Ophthalmic Solution 1.0%
15 Minutes post-dose: 7 Minutes post CAC	0.3 ± 0.5	0.7 ± 0.7	0.2 ± 0.5
15 Minutes post-dose: 15 Minutes post CAC	0.3 ± 0.5	0.8 ± 0.7	0.2 ± 0.6
15 Minutes post-dose: 20 Minutes post CAC	0.3 ± 0.5	0.9 ± 0.7	0.3 ± 0.6
8 Hours post-dose: 7 Minutes post CAC	0.4 ± 0.7	0.7 ± 0.7	0.3 ± 0.5
8 Hours post-dose: 15 Minutes post CAC	0.5 ± 0.8	0.9 ± 0.9	0.4 ± 0.6
8 Hours post-dose: 20 Minutes post CAC	0.5 ± 0.7	0.9 ± 0.9	0.4 ± 0.6
16 Hours post-dose: 7 Minutes post CAC	0.5 ± 0.6	0.7 ± 0.7	0.3 ± 0.5
16 Hours post-dose: 15 Minutes post CAC	0.5 ± 0.7	0.9 ± 0.9	0.4 ± 0.6
16 Hours post-dose: 20 Minutes post CAC	0.5 ± 0.7	0.8 ± 0.8	0.5 ± 0.6

SecondaryTotal Nasal Symptom

Total Nasal 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

Time frame:: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Reported as:: Mean · Units on a scale

Total Nasal Symptom
Units on a scale	Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	Placebo	Bepotastine Besilate Ophthalmic Solution 1.0%
15 Minutes post-dose: 7 Minutes post CAC	1.3 ± 2.2	3.2 ± 3.1	0.4 ± 0.8
15 Minutes post-dose: 15 Minutes post CAC	1.7 ± 2.2	4.0 ± 3.4	0.9 ± 1.5
15 Minutes post-dose: 20 Minutes post CAC	1.6 ± 2.2	3.6 ± 3.2	1.0 ± 1.6
8 Hours post-dose: 7 Minutes post CAC	0.7 ± 1.6	2.9 ± 3.1	1.3 ± 2.4
8 Hours post-dose: 15 Minutes post CAC	1.3 ± 2.2	4.8 ± 4.0	1.6 ± 2.5
8 Hours post-dose: 20 Minutes post CAC	1.5 ± 2.4	4.0 ± 4.0	1.5 ± 2.4
16 Hours post-dose: 7 Minutes post CAC	1.8 ± 2.0	3.4 ± 3.2	1.3 ± 2.6
16 Hours post-dose: 15 Minutes post CAC	2.5 ± 2.9	4.5 ± 4.0	2.7 ± 3.1
16 Hours post-dose: 20 Minutes post CAC	2.6 ± 3.1	4.0 ± 4.3	2.8 ± 3.3

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	—	0/35 (0%)	4/35 (11.4%)
Placebo	—	0/36 (0%)	2/36 (5.6%)
Bepotastine Besilate Ophthalmic Solution 1.0%	—	0/36 (0%)	8/36 (22.2%)

Most frequent other events

Most frequent other events
Event	Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	Placebo	Bepotastine Besilate Ophthalmic Solution 1.0%
Mild TasteNervous system disorders	3/35	0/36	6/36
Eye IrritationEye disorders	1/35	2/36	0/36
NasopharyngitisInfections and infestations	0/35	0/36	2/36

Baseline characteristics

Age, Customized
Age, Customized(participants)	Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	Placebo	Bepotastine Besilate Ophthalmic Solution 1.0%	Total
<18 years	2	2	3	7
>=18 years	33	34	33	100

Age Continuous
Age Continuous(years)	Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	Placebo	Bepotastine Besilate Ophthalmic Solution 1.0%	Total
Mean	44.3 ± 16.0	40.9 ± 11.4	39.9 ± 15.2	41.7 ± 14.3

Sex: Female, Male
Sex: Female, Male(Participants)	Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%	Placebo	Bepotastine Besilate Ophthalmic Solution 1.0%	Total
Female	18	17	14	49
Male	17	19	22	58

Study locations

1 site

ISTA Pharmaceuticals, Inc.
Irvine, California 92630, United States

References and documents

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 ↗
Torkildsen GL, Williams JI, Gow JA, Gomes PJ, Abelson MB, McNamara TR; Bepotastine Besilate Ophthalmic Solutions Clinical Study Group. Bepotastine besilate ophthalmic solution for the relief of nonocular symptoms provoked by conjunctival allergen challenge. Ann Allergy Asthma Immunol. 2010 Jul;105(1):57-64. doi: 10.1016/j.anai.2010.04.005. PubMed 20642205 ↗
Abelson MB, Torkildsen GL, Williams JI, Gow JA, Gomes PJ, McNamara TR; Bepotastine Besilate Ophthalmic Solutions Clinical Study Group. Time to onset and duration of action of the antihistamine bepotastine besilate ophthalmic solutions 1.0% and 1.5% in allergic conjunctivitis: a phase III, single-center, prospective, randomized, double-masked, placebo-controlled, conjunctival allergen challenge assessment in adults and children. Clin Ther. 2009 Sep;31(9):1908-21. doi: 10.1016/j.clinthera.2009.09.001. PubMed 19843481 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2007 and a primary completion of Jul 2007. It does not say whether these dates are actual or estimated.

Results were first posted in Mar 2012, 4 years 8 months after primary completion. A results delay was requested in Oct 2009.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 17, 2007
First posted: Jan 19, 2007
Start: Feb 2007
Primary completionActual: Jul 2007
Results delay requested: Oct 8, 2009
Results first posted: Mar 26, 2012
Last update: Feb 15, 2013

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00424398
Lead sponsor: Bausch & Lomb Incorporated
Responsible party: Sponsor
First posted: Jan 19, 2007
Start date: Feb 2007
Primary completion: Jul 2007
Results posted: Mar 26, 2012
Last update: Feb 15, 2013

Study contacts

Jon Williams, PhD

study director · ISTA Pharmaceuticals, Inc.

View the source record on ClinicalTrials.gov ↗

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