NCT01450176

Completed

Comparing Patient Satisfaction With Pataday or Bepreve

McCabe Vision Center Source

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Other study identifiers

Sponsor study identifier

MAC-04-11

Secondary identifiers

3776-001

REGISTRY · Sterling IRB

Study Type

interventional

Actual enrollment (reported)

30

Locations

1 country

Sites

1

Timeline

Study Start

September 2011

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2011

Actual (reported)

Study Completion

December 2011

Actual (reported)

Brief Summary

The purpose of this study is to compare patient satisfaction with Pataday (Olopatadine hydrochloride 0.2%) one daily (QD) and Bepreve (Bepotastine besilate ophthalmic solution 1.5%) two times a day (BID).

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 30 participants
Study completion date: December 2011
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2011
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
October 2011
Actual (reported)
First Submitted
October 7, 2011
Actual (reported)
First Posted
October 12, 2011
Actual (reported)
Study Completion
December 2011
Actual (reported)

Last Updated: January 9, 2014
Status Verified: January 2014
Last Update Submitted: January 8, 2014

Conditions

Eye Allergies

Keywords

eyeitchingallergies

Outcome Measures

Primary Outcomes (1)

Relief of ocular itching
All day relief of ocular itching throughout the treatment period.
5 weeks

Secondary Outcomes (1)

Patient preference
5 weeks

Study Arms (2)

Pataday once daily

ACTIVE COMPARATOR

15 subjects will administer Pataday once daily for 2 weeks. Then these subjects will administer Bepreve twice daily for 2 weeks.

Drug: Olopatadine hydrochloride 0.2%

Bepreve twice daily

ACTIVE COMPARATOR

Bepreve twice daily for 2 weeks, then subjects will use Pataday once daily for 2 weeks

Drug: Bepotastine besilate ophthalmic solution 1.5%

Interventions

Olopatadine hydrochloride 0.2%Drug

1 drop in each eye once daily for 2 weeks

Also known as: Pataday

Pataday once daily

Bepotastine besilate ophthalmic solution 1.5%Drug

1 drop in each eye twice daily for 2 weeks

Also known as: Bepreve

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Be male or female subjects of any racial/ethnic group.
Be at least 18 years of age or older.

Sponsors & Collaborators

McCabe Vision Center
Otherlead

Study Sites (1)

McCabe Vision Center

Murfreesboro, Tennessee, 37129, United States

MeSH Terms

Conditions

PruritusHypersensitivity

Interventions

Olopatadine Hydrochloridebepotastine besilate

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsImmune System Diseases

Intervention Hierarchy (Ancestors)

DibenzoxepinsHeterocyclic Compounds, 3-Ring

Enrollment

30 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 7, 2011

First Posted

October 12, 2011

Study Start

September 2011

Date type not reported

This date has not been verified as actual or estimated.

NCT00586664

Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis

Phase 3Completed

NCT01443442

Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis

Phase 4Completed

NCT00424398

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

Phase 2/3Completed

NCT01697969

Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients

Phase 4Completed

NCT01128556

The Evaluation of Bepreve on the Measurement of Wheal and Flare Response From Histamine Skin Prick Testing

Phase 4Completed

NCT01109485

Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric Patients

Phase 4Completed

Bepreve twice daily

Have a diagnosis of allergic conjunctivitis with active symptoms, with no concurrent ocular allergy associated conditions and no plans to have ocular surgery during study period.

Willing and able to return for all required visits and follow instructions from investigator and staff.

Able to self-administer test article (TA) or have a caregiver available to instill all doses of TA.

If a woman, capable of becoming pregnant, agrees to have pregnancy testing performed at screening (must be negative) and agrees to use a medically acceptable form of birth control (intrauterine device, birth control pill, patch or subcutaneous implant, condoms, diaphragm, and abstinence) throughout the study duration and for at least one week prior to and one week after completion of the study. Women considered capable of becoming pregnant include all females who have experienced menarche and who have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).

Sign and date the informed consent form approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC).

Be willing/able to return for all required study visits, to follow instructions from the study investigator and his/her staff, and to complete and return the Screening and Subject Diaries.

You may not qualify if:

Have known hypersensitivity to BEPREVE or PATADAY or any of their components.
Are actively taking steroids or antihistamines during the study or within 7 days prior to enrolling in the study.
Are pregnant, planning to become pregnant, or nursing/lactating.
Have a known history of alcohol or drug abuse.
Participated in a study of an investigational drug or device within the past 30 days prior to enrolling in the study.
Have a presence of an active ocular infection (bacterial, viral or fungal), positive history of an ocular herpetic infection, or preauricular lymphadenopathy at any visit.
Have any significant illness {eg: any autoimmune disease, or severe cardiovascular disease (including arrhythmias)}that the Investigator feels could be expected to interfere with the subject's safety or study parameters and/or put the subject at anyh unnecessary risk.

Contact the study team to confirm eligibility.

Heterocyclic Compounds, Fused-Ring

Heterocyclic Compounds

Primary Completion

October 2011

Actual (reported)

Study Completion

December 2011

Actual (reported)

Last Updated

January 9, 2014

Record last verified: 2014-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01450176
Data provider: ClinicalTrials.gov
Source updated: 2014-01-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:18:20 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Pataday once daily

Bepreve twice daily

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations