Comparing Patient Satisfaction With Pataday or Bepreve
This study is currently recruiting participants.
Verified October 2011 by McCabe Vision Center
Sponsor:
McCabe Vision Center
Information provided by (Responsible Party):
McCabe Vision Center
ClinicalTrials.gov Identifier:
NCT01450176
First received: October 7, 2011
Last updated: October 11, 2011
Last verified: October 2011
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Eye Allergies |
Drug: Olopatadine hydrochloride 0.2% Drug: Bepotastine besilate ophthalmic solution 1.5% |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparing Patient Satisfaction Throughout the Day With PATADAY (OLOPATADINE HYDROCHLORIDE) 0.2% QD or BEPREVE (BEPOTASTINE BESILATE OPHTHALMIC SOLUTION) 1.5% BID |
Resource links provided by NLM:
Further study details as provided by McCabe Vision Center:
Primary Outcome Measures:
- Relief of ocular itching [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]All day relief of ocular itching throughout the treatment period.
Secondary Outcome Measures:
- Patient preference [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]Patient satisfaction, preference, and comfort with treatment
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: Bepreve
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01450176
Contacts
| Contact: HELEN BALDWIN, A.S., C.O.T. | 615-904-9024 | helen@mccabevisioncenter.com |
| Contact: AMY NORTHCUTT | 615-904-9024 | amy@mccabevisioncenter.com |
Locations
| United States, Tennessee | |
| McCabe Vision Center | Recruiting |
| Murfreesboro, Tennessee, United States, 37129 | |
| Principal Investigator: Craig F. McCabe, MD, PhD, FACS | |
Sponsors and Collaborators
McCabe Vision Center
More Information
No publications provided
| Responsible Party: | McCabe Vision Center |
| ClinicalTrials.gov Identifier: | NCT01450176 History of Changes |
| Other Study ID Numbers: | MAC-04-11, 3776-001 |
| Study First Received: | October 7, 2011 |
| Last Updated: | October 11, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by McCabe Vision Center:
|
eye itching allergies |
Additional relevant MeSH terms:
|
Hypersensitivity Immune System Diseases Olopatadine Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
Anti-Allergic Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013