NCT00586664

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 4, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

March 26, 2012

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

8 months

First QC Date

December 21, 2007

Results QC Date

October 8, 2009

Last Update Submit

February 4, 2013

Conditions

Allergic Conjunctivitis

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 & 16 Hours post-dose from Conjunctival Allergen Challenge (CAC) Model

  • Eyelid Swelling

    15 Minutes, 8 Hours & 16 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

  • +6 more secondary outcomes

Study Arms (3)

Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%

EXPERIMENTAL
Drug: Bepreve (bepotastine besilate ophthalmic solution) 1.5%

Bepotastine Besilate Ophthalmic Solution 1.0%

EXPERIMENTAL
Drug: Bepotastine Besilate Ophthalmic Solution 1.0%

Placebo

PLACEBO COMPARATOR
Drug: placebo comparator

Interventions

Bepreve (bepotastine besilate ophthalmic solution) 1.5%DRUG

sterile ophthalmic solution

Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%
placebo comparatorDRUG

sterile ophthalmic solution

Placebo
Bepotastine Besilate Ophthalmic Solution 1.0%DRUG

sterile ophthalmic solution

Bepotastine Besilate Ophthalmic Solution 1.0%

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must be at least 10 years of age

You may not qualify if:

  • No active ocular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ISTA Pharmaceuticals, Inc.

Irvine, California, 92618, United States

Location

Related Publications (2)

  • 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: 22991696DERIVED

  • Macejko TT, Bergmann MT, Williams JI, Gow JA, Gomes PJ, McNamara TR, Abelson MB; Bepotastine Besilate Ophthalmic Solutions Clinical Study Group. Multicenter clinical evaluation of bepotastine besilate ophthalmic solutions 1.0% and 1.5% to treat allergic conjunctivitis. Am J Ophthalmol. 2010 Jul;150(1):122-127.e5. doi: 10.1016/j.ajo.2010.02.007. Epub 2010 May 20.

    PMID: 20488431DERIVED

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

bepotastine besilate

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune 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

  • Tim McNamara, PharmD

    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 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 4, 2008

Study Start

October 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

February 8, 2013

Results First Posted

March 26, 2012

Record last verified: 2013-02

Locations

US(1)