Comparing Patient Satisfaction With Pataday or Bepreve

Comparing Patient Satisfaction Throughout the Day With PATADAY (OLOPATADINE HYDROCHLORIDE) 0.2% QD or BEPREVE (BEPOTASTINE BESILATE OPHTHALMIC SOLUTION) 1.5% BID

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).

Study Overview

• Status: Completed
• Conditions: Eye Allergies
• Intervention / Treatment: Drug: Olopatadine hydrochloride 0.2%; Drug: Bepotastine besilate ophthalmic solution 1.5%

Detailed Description

5 week randomized study with 15 subjects using Pataday qd for 2 weeks, and the other 15 subjects using Bepreve BID for 2 weeks. Following a one-week washout period, the two groups are given the opposite test article (TA) for 2 weeks. Subjects to complete daily diary regarding effects of drug and are seen in clinic for 3 exams.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37129
      • McCabe Vision Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pataday once daily; 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%; 1 drop in each eye once daily for 2 weeks; Other Names: Pataday
Active Comparator: Bepreve twice daily; Bepreve twice daily for 2 weeks, then subjects will use Pataday once daily for 2 weeks	Drug: Bepotastine besilate ophthalmic solution 1.5%; 1 drop in each eye twice daily for 2 weeks; Other Names: Bepreve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relief of ocular itching	All day relief of ocular itching throughout the treatment period.	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient preference	Patient satisfaction, preference, and comfort with treatment	5 weeks

Collaborators and Investigators

• Sponsor: McCabe Vision Center

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: October 7, 2011
• First Submitted That Met QC Criteria: October 11, 2011
• First Posted (Estimate): October 12, 2011

Study Record Updates

• Last Update Posted (Estimate): January 9, 2014
• Last Update Submitted That Met QC Criteria: January 8, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: eye; itching; allergies
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Pharmaceutical Solutions; Histamine H1 Antagonists, Non-Sedating; Ophthalmic Solutions; Bepotastine besilate; Olopatadine Hydrochloride
• Other Study ID Numbers: MAC-04-11; 3776-001 (Registry Identifier: Sterling IRB)