Ocular Allergy Treatment Practical Impact Trial
(OAT-PIT)
To Assess the Impact of Ocular Allergy Treatment on Patients Using an Opthalmic Agent (or no Treatment) Versus Alcaftadine(Lastacaft™)
1 other identifier
interventional
50
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2013
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2013
CompletedFirst Posted
Study publicly available on registry
March 11, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedMay 30, 2013
March 1, 2013
6 months
March 6, 2013
May 29, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Quality of Life- Eye Allergy Patient Impact Questionnaire
4 months
Secondary Outcomes (1)
Ocular Surface Disease Index Pollen Count correlation of symptoms
6 months
Study Arms (1)
Alcaftadine
EXPERIMENTALsubject 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
Interventions
Alcaftadine 0.25% one dorp each eye daily for 1-2 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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) -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
STARx Research Center
Edison, New Jersey, 08820, United States
STARx
Springfield, New Jersey, 07081, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jayesh Kanuga, MD
Starx Research Center, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
March 6, 2013
First Posted
March 11, 2013
Study Start
April 1, 2013
Primary Completion
October 1, 2013
Study Completion
November 1, 2013
Last Updated
May 30, 2013
Record last verified: 2013-03