NCT00586625

Brief Summary

Safety study for bepotastine besilate ophthalmic solution in normal volunteers

Trial Health

100
On Track

Trial Health Score

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

Enrollment
861

participants targeted

Target at P75+ for phase_3

Status
completed

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

Trial Relationships

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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
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

November 11, 2009

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

7 months

First QC Date

December 21, 2007

Results QC Date

October 8, 2009

Last Update Submit

February 13, 2013

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Ocular Comfort

    A 4-step grading scale with half unit (1-step) increments allowed: 0=Comfortable;discomfort absent; 1.0=Generally comfortable; mild discomfort; 2.0=Some discomfort but tolerable; moderate comfort; 3.0=Severely uncomfortable or intolerable

    Day 8 & Day 22

Study Arms (2)

Bepreve

EXPERIMENTAL

bepotastine besilate ophthalmic solution 1.5%

Drug: Bepreve

Placebo

PLACEBO COMPARATOR

vehicle

Drug: Placebo

Interventions

BepreveDRUG

One drop, both eyes, twice a day

Bepreve
PlaceboDRUG

One drop, both eyes, twice a day

Placebo

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must be at least 3 years of age, and have ocular health within normal limits

You may not qualify if:

  • No active ocular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
DOUBLE
Who Masked
PARTICIPANT, 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

May 1, 2008

Last Updated

February 15, 2013

Results First Posted

November 11, 2009

Record last verified: 2013-02