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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00586664
First received: December 21, 2007
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Allergic Conjunctivitis
Drug: Bepreve (bepotastine besilate ophthalmic solution) 1.5%
Drug: placebo comparator
Drug: Bepotastine Besilate Ophthalmic Solution 1.0%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Ocular Itching [ Time Frame: 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Ciliary Redness [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ] [ Designated as safety issue: No ]
    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

  • Eyelid Swelling [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ] [ Designated as safety issue: No ]
    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

  • Rhinorrhea (Runny Nose) [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

  • Total Non-Ocular Composite Symptom [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ] [ Designated as safety issue: No ]
    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

  • Tearing [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ] [ Designated as safety issue: No ]
    Percent of Eyes with Tearing as measured 7, 15 & 20 minutes post-CAC. Scored as absent or present

  • Ocular Mucus Discharge [ Time Frame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model ] [ Designated as safety issue: No ]

    Percent of Eyes with Ocular Mucus Discharge as measured 7, 15 & 20 minutes post-CAC.

    Scored as absent or present



Enrollment: 130
Study Start Date: October 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% Drug: Bepreve (bepotastine besilate ophthalmic solution) 1.5%
sterile ophthalmic solution
Experimental: Bepotastine Besilate Ophthalmic Solution 1.0% Drug: Bepotastine Besilate Ophthalmic Solution 1.0%
sterile ophthalmic solution
Placebo Comparator: Placebo Drug: placebo comparator
sterile ophthalmic solution

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be at least 10 years of age

Exclusion Criteria:

  • No active ocular disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586664

Locations
United States, California
ISTA Pharmaceuticals, Inc.
Irvine, California, United States, 92618
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.
  More Information

No publications provided by Bausch & Lomb Incorporated

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00586664     History of Changes
Other Study ID Numbers: CL-S&E-0409071-P
Study First Received: December 21, 2007
Results First Received: October 8, 2009
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014