Comparing Patient Satisfaction With Pataday or Bepreve

NCT01450176 | Completed

• 2 other identifiers: MAC-04-113776-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Eye Allergies

Keywords

eye; itching; allergies

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

Bepreve twice daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• 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.

Sponsors & Collaborators

• McCabe Vision Center: lead

Study Sites (1)

McCabe Vision Center

Murfreesboro, Tennessee, 37129, United States

Location

MeSH Terms

Conditions

Pruritus; Hypersensitivity

Interventions

Olopatadine Hydrochloride; bepotastine besilate

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 9, 2014

Record last verified: 2014-01

Locations

US (1)