Clinical trial NCT00424398: Evaluation of the Onset and Duration of Action of Bepotastine Besilate Ophthalmic Solution in Acute Allergic Conjunctivitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Conjunctivitis, Allergic
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2007-01-19
Enrollment: 107
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Ocular Itching
timeFrame: 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model
measure: Conjunctival Redness
timeFrame: 15 minutes, 8 hours & 16 hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Secondary outcomes:
measure: Ciliary Redness
timeFrame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
measure: Episcleral Redness
timeFrame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
measure: Chemosis
timeFrame: 15 Minutes, 8 Hours & s6 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
measure: Rhinorrhea (Runny Nose)
timeFrame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
measure: Nasal Pruritus (Itchy Nose)
timeFrame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
measure: Ear or Palate Pruritus (Itchy Ear or Palate)
timeFrame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
measure: Nasal Congestion
timeFrame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen challenge (CAC) Model
measure: Tearing
timeFrame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
measure: Ocular Mucus Discharge
timeFrame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
measure: Eyelid Swelling
timeFrame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
measure: Total Nasal Symptom
timeFrame: 15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model
Other outcomes:
Locations:
city: Irvine
country: United States
facility: ISTA Pharmaceuticals, Inc.
state: California
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Jon Williams, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.