Back to resultsOcular Allergy Treatment Practical Impact Trial ((OAT-PIT))
Primary Purpose
Allergic Conjunctivitis, Rhinoconjunctivitis
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Alcaftadine
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- patients age 18 and older with a history of seasonal or perennial forms of allergic conjunctivitis and skin test positive reactivity to seasonal aeroallergens
- Total Ocular Symptom Score (TOSS) on the day of enrollment of 4 or more.
- have allergic ocular symptoms for the past week for which they are either treating with ophthalmic agents or have had no treatment.
- Are willing/able to follow instructions from the study investigator and his/her study staff.
Have signed infromed consent approved by Institutional Review Board or Independent Ethics Committee.
-
Exclusion Criteria:
- Active ocular infection;
- History of retinal detachment, diabetic neuropathy, or any progressive retinal disease;
- Ocular surgical intervention within three (3) months prior to visit 1 or scheduled during the study.
- History of unstable, or uncontrolled disease of any nature.
- Pregnancy or lactation;
- Have a known hypersensitivity tp LASTACAFT™ (alcaftadine) -
Sites / Locations
- STARx Research CenterRecruiting
- STARxRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Alcaftadine
Arm Description
subject on any ocular allergy ophthalmic treatment or no treatment will be started on Alcaftadine 0.25%(study drug)- 1 drop each eye daily for 1-2 weeks
Outcomes
Primary Outcome Measures
Quality of Life- Eye Allergy Patient Impact Questionnaire
Secondary Outcome Measures
Ocular Surface Disease Index Pollen Count correlation of symptoms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01808768
Brief Title
Ocular Allergy Treatment Practical Impact Trial
Acronym
(OAT-PIT)
Official Title
To Assess the Impact of Ocular Allergy Treatment on Patients Using an Opthalmic Agent (or no Treatment) Versus Alcaftadine(Lastacaft™)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
November 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Starx Research Center, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To study the impact of alcaftadine in patients treated with other opthalmic ocular agents (or specific topical opthalmic treatment) in an allergy subspecialist outpatient setting.
Detailed Description
To assess the impact of ocular allergy treatment on patients using an ophthalmic agent (or no treatment) versus alcaftadine(Lastacaft™)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis, Rhinoconjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alcaftadine
Arm Type
Experimental
Arm Description
subject on any ocular allergy ophthalmic treatment or no treatment will be started on Alcaftadine 0.25%(study drug)- 1 drop each eye daily for 1-2 weeks
Intervention Type
Drug
Intervention Name(s)
Alcaftadine
Other Intervention Name(s)
Lastacaft
Intervention Description
Alcaftadine 0.25% one dorp each eye daily for 1-2 weeks.
Primary Outcome Measure Information:
Title
Quality of Life- Eye Allergy Patient Impact Questionnaire
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Ocular Surface Disease Index Pollen Count correlation of symptoms
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients age 18 and older with a history of seasonal or perennial forms of allergic conjunctivitis and skin test positive reactivity to seasonal aeroallergens
Total Ocular Symptom Score (TOSS) on the day of enrollment of 4 or more.
have allergic ocular symptoms for the past week for which they are either treating with ophthalmic agents or have had no treatment.
Are willing/able to follow instructions from the study investigator and his/her study staff.
Have signed infromed consent approved by Institutional Review Board or Independent Ethics Committee.
-
Exclusion Criteria:
Active ocular infection;
History of retinal detachment, diabetic neuropathy, or any progressive retinal disease;
Ocular surgical intervention within three (3) months prior to visit 1 or scheduled during the study.
History of unstable, or uncontrolled disease of any nature.
Pregnancy or lactation;
Have a known hypersensitivity tp LASTACAFT™ (alcaftadine) -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jayesh Kanuga, MD
Phone
732-906-1747
Email
jkanuga@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Erika Julca, LPN,CRC
Phone
732-906-1747
Email
ejulca1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayesh Kanuga, MD
Organizational Affiliation
Starx Research Center, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
STARx Research Center
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08820
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Julca, lpn,crc
Phone
732-906-1747
Email
ejulca1@gmail.com
First Name & Middle Initial & Last Name & Degree
June Pepe, lpn, ccrc
Phone
973-912-9817
Email
pepejune@gmail.com
First Name & Middle Initial & Last Name & Degree
Jayesh Kanuga, MD
First Name & Middle Initial & Last Name & Degree
Ligaya Centeno, MD
First Name & Middle Initial & Last Name & Degree
Ruby Reyes, MD
First Name & Middle Initial & Last Name & Degree
Leonard Bielory, MD
Facility Name
STARx
City
Springfield
State/Province
New Jersey
ZIP/Postal Code
07081
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonard Bielory, MD
Phone
973-912-9817
Email
DrLBielory@gmail.com
First Name & Middle Initial & Last Name & Degree
Leonard Bielory, MD
12. IPD Sharing Statement
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Ocular Allergy Treatment Practical Impact Trial
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