Evaluation of the Onset and Duration of Action of Bepotastine Besilate Ophthalmic Solution in Acute Allergic Conjunctivitis
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ClinicalTrials.gov Identifier: NCT00424398 |
Recruitment Status :
Completed
First Posted : January 19, 2007
Results First Posted : March 26, 2012
Last Update Posted : February 15, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Conjunctivitis, Allergic | Drug: Bepreve Drug: Placebo Drug: Bepotastine Besilate | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 107 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Single-Center, Double-Masked, Randomized, Placebo-Controlled, Evaluation of the Onset and Duration of Action of Bepotastine Besilate Ophthalmic Solution in Acute Allergic Conjunctivitis |
Study Start Date : | February 2007 |
Actual Primary Completion Date : | July 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Bepreve
Bepotastine Besilate Ophthalmic Solution 1.5%
|
Drug: Bepreve
sterile ophthalmic solution |
Placebo Comparator: Placebo
sterile ophthalmic solution
|
Drug: Placebo
sterile ophthalmic solution |
Experimental: Bepotastine Besilate
sterile ophthalmic solution 1.0%
|
Drug: Bepotastine Besilate
sterile ophthalmic solution |
- 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
- Ciliary Redness [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]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
- Episcleral Redness [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]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
- Chemosis [ Time Frame: 15 Minutes, 8 Hours & s6 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]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
- Rhinorrhea (Runny Nose) [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]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
- Nasal Pruritus (Itchy Nose) [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]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
- Ear or Palate Pruritus (Itchy Ear or Palate) [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]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
- Nasal Congestion [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen challenge (CAC) Model ]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
- Tearing [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]Percent of Eyes with Tearing. Scored as absent or present
- Ocular Mucus Discharge [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]Percent of Eyes with Ocular Mucus Discharge. Scored as absent or present
- Eyelid Swelling [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]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
- Total Nasal Symptom [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ]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

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Ages Eligible for Study: | 10 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- Have planned surgery during trial period
- Female currently pregnant, planning a pregnancy, or lactating

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424398
United States, California | |
ISTA Pharmaceuticals, Inc. | |
Irvine, California, United States, 92630 |
Study Director: | Jon Williams, PhD | ISTA Pharmaceuticals, Inc. |
Responsible Party: | Bausch & Lomb Incorporated |
ClinicalTrials.gov Identifier: | NCT00424398 |
Other Study ID Numbers: |
ISTA-BEPO-CS01 |
First Posted: | January 19, 2007 Key Record Dates |
Results First Posted: | March 26, 2012 |
Last Update Posted: | February 15, 2013 |
Last Verified: | February 2013 |
Conjunctivitis Conjunctivitis, Allergic Conjunctival Diseases Eye Diseases Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Bepotastine besilate Anti-Allergic Agents |