Ocular Allergy Treatment Practical Impact Trial ((OAT-PIT))

May 29, 2013 updated by: Jayesh G. Kanuga, M.D., Starx Research Center, LLC

To Assess the Impact of Ocular Allergy Treatment on Patients Using an Opthalmic Agent (or no Treatment) Versus Alcaftadine(Lastacaft™)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To assess the impact of ocular allergy treatment on patients using an ophthalmic agent (or no treatment) versus alcaftadine(Lastacaft™)

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Edison, New Jersey, United States, 08820
        • Recruiting
        • STARx Research Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jayesh Kanuga, MD
        • Sub-Investigator:
          • Ligaya Centeno, MD
        • Sub-Investigator:
          • Ruby Reyes, MD
        • Sub-Investigator:
          • Leonard Bielory, MD
      • Springfield, New Jersey, United States, 07081
        • Recruiting
        • STARx
        • Sub-Investigator:
          • Leonard Bielory, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  1. patients age 18 and older with a history of seasonal or perennial forms of allergic conjunctivitis and skin test positive reactivity to seasonal aeroallergens
  2. Total Ocular Symptom Score (TOSS) on the day of enrollment of 4 or more.
  3. have allergic ocular symptoms for the past week for which they are either treating with ophthalmic agents or have had no treatment.
  4. Are willing/able to follow instructions from the study investigator and his/her study staff.

  5. Have signed infromed consent approved by Institutional Review Board or Independent Ethics Committee.

    -

Exclusion Criteria:

  1. Active ocular infection;
  2. History of retinal detachment, diabetic neuropathy, or any progressive retinal disease;
  3. Ocular surgical intervention within three (3) months prior to visit 1 or scheduled during the study.
  4. History of unstable, or uncontrolled disease of any nature.
  5. Pregnancy or lactation;
  6. Have a known hypersensitivity tp LASTACAFT™ (alcaftadine) -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Alcaftadine
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
Drug: Alcaftadine
Alcaftadine 0.25% one dorp each eye daily for 1-2 weeks.
Other Names:
  • Lastacaft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of Life- Eye Allergy Patient Impact Questionnaire
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Ocular Surface Disease Index Pollen Count correlation of symptoms
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Starx Research Center, LLC

Investigators

  • Principal Investigator: Jayesh Kanuga, MD, Starx Research Center, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ANTICIPATED)

October 1, 2013

Study Completion (ANTICIPATED)

November 1, 2013

Study Registration Dates

First Submitted

March 6, 2013

First Submitted That Met QC Criteria

March 7, 2013

First Posted (ESTIMATE)

March 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 30, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID IIT- 000373

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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