NCT01174823

Brief Summary

The purpose of this study is to study the safety and efficacy of bepotastine besilate ophthalmic solution in allergic conjunctivitis patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
245

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_2

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

June 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
9.8 years until next milestone

Results Posted

Study results publicly available

September 14, 2020

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

August 2, 2010

Results QC Date

August 24, 2020

Last Update Submit

September 11, 2020

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Mean Change in Total Score

    Responses to questions relating to symptoms and daily activities in the RQLQ were provided for 28 questions encompassing the 7 major domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional state. Each response to an RQLQ question was provided on a scale of 0-6 units, where 0 = not troubled/none of the time and 6 = extremely troubled/all of the time. The minimum total score was 0 units and the maximum total score was 42 units, with higher score indicating decreased quality of life due to rhinoconjunctivitis.

    Baseline, 14 days

Secondary Outcomes (6)

  • Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Ocular Itching Scores Over the Treatment Period

    Baseline, 14 days

  • Mean Change From Baseline for Twice Daily (BID) Averaged Instantaneous Ocular Redness Scores Over the Treatment Period

    Baseline, 14 days

  • Mean Change From Baseline for Twice Daily (BID) Averaged Proportion of Tearing Episodes Over the Treatment Period

    Baseline, 14 days

  • Mean Change From Baseline for Twice Daily (BID) Averaged Reflective Total Nasal Symptom Scores Over the Treatment Period

    Baseline, 14 days

  • Global Therapeutic Response Rating - Participant Assessed

    14 days

  • +1 more secondary outcomes

Study Arms (2)

Bepotastine Besilate Ophthalmic Solution

EXPERIMENTAL
Drug: bepotastine besilate ophthalmic solution

Placebo

PLACEBO COMPARATOR
Drug: placebo comparator ophthalmic solution

Interventions

bepotastine besilate ophthalmic solutionDRUG

sterile ophthalmic solution

Bepotastine Besilate Ophthalmic Solution
placebo comparator ophthalmic solutionDRUG

sterile ophthalmic solution

Placebo

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects 12 years of age and older with 2-year history of allergic conjunctivitis

You may not qualify if:

  • No active ocular or nasal infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ISTA Pharmaceuticals, Inc.

Irvine, California, 92618, United States

Location

Related Publications (1)

  • Carr WW, Nayak AS, Ratner PH, Gow JA, McNamara TR, Williams JI; Bepotastine Besilate Ophthalmic Solution 1.5% (Bepreve) Study Group. Efficacy of bepotastine besilate ophthalmic solution 1.5% for seasonal allergic conjunctivitis: a randomized, placebo-controlled, natural exposure, clinical trial. Allergy Asthma Proc. 2013 May-Jun;34(3):247-54. doi: 10.2500/aap.2013.34.3671.

    PMID: 23484763DERIVED

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Study Director
Organization
Bausch Health
susan.harris@bauschhealth.com
908-300-9920

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 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

August 2, 2010

First Posted

August 4, 2010

Study Start

June 1, 2010

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

September 14, 2020

Results First Posted

September 14, 2020

Record last verified: 2020-09

Locations

US(1)