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

NCT00424398 | Completed Phase 2 Results

• 1 other identifier: ISTA-BEPO-CS01
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Conjunctivitis, Allergic

Outcome Measures

Primary Outcomes (2)

• 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

  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

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

Secondary Outcomes (11)

• Ciliary Redness

  15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model

• Episcleral Redness

  15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model

• Chemosis

  15 Minutes, 8 Hours & s6 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model

• Rhinorrhea (Runny Nose)

  15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model

• Nasal Pruritus (Itchy Nose)

  15 Minutes, 8 Hours & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model

Study Arms (3)

Bepreve

EXPERIMENTAL

Bepotastine Besilate Ophthalmic Solution 1.5%

Drug: Bepreve

Placebo

PLACEBO COMPARATOR

sterile ophthalmic solution

Drug: Placebo

Bepotastine Besilate

EXPERIMENTAL

sterile ophthalmic solution 1.0%

Drug: Bepotastine Besilate

Interventions

Bepreve DRUG

sterile ophthalmic solution

Bepreve

Placebo DRUG

sterile ophthalmic solution

Placebo

Bepotastine Besilate DRUG

sterile ophthalmic solution

Bepotastine Besilate

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

ISTA Pharmaceuticals, Inc.

Irvine, California, 92630, United States

Location

Related Publications (3)

• 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.

  PMID: 22991696 DERIVED

• 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.

  PMID: 20642205 DERIVED

• 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.

  PMID: 19843481 DERIVED

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

bepotastine besilate

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Vice President, Clinical Research & Medical Affairs
• Organization: ISTA Pharmaceuticals, Inc.

tmcnamara@istavision.com

949-788-6000

Study Officials

• Jon Williams, PhD

  ISTA Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2007
• First Posted: January 19, 2007
• Study Start: February 1, 2007
• Primary Completion: July 1, 2007
• Last Updated: February 15, 2013
• Results First Posted: March 26, 2012

Record last verified: 2013-02

Locations

US (1)