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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Starx Research Center, LLC
Sponsor:
Information provided by (Responsible Party):
Jayesh G. Kanuga, M.D., Starx Research Center, LLC
ClinicalTrials.gov Identifier:
NCT01808768
First received: March 6, 2013
Last updated: May 29, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Allergic Conjunctivitis
Rhinoconjunctivitis
Drug: Alcaftadine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: To Assess the Impact of Ocular Allergy Treatment on Patients Using an Opthalmic Agent (or no Treatment) Versus Alcaftadine(Lastacaft™)

Resource links provided by NLM:


Further study details as provided by Starx Research Center, LLC:

Primary Outcome Measures:
  • Quality of Life- Eye Allergy Patient Impact Questionnaire [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ocular Surface Disease Index Pollen Count correlation of symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2013
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lastacaft

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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) -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01808768

Contacts
Contact: Jayesh Kanuga, MD 732-906-1747 jkanuga@gmail.com
Contact: Erika Julca, LPN,CRC 732-906-1747 ejulca1@gmail.com

Locations
United States, New Jersey
STARx Research Center Recruiting
Edison, New Jersey, United States, 08820
Contact: Erika Julca, lpn,crc    732-906-1747    ejulca1@gmail.com   
Contact: June Pepe, lpn, ccrc    973-912-9817    pepejune@gmail.com   
Principal Investigator: Jayesh Kanuga, MD         
Sub-Investigator: Ligaya Centeno, MD         
Sub-Investigator: Ruby Reyes, MD         
Sub-Investigator: Leonard Bielory, MD         
STARx Recruiting
Springfield, New Jersey, United States, 07081
Contact: Leonard Bielory, MD    973-912-9817    DrLBielory@gmail.com   
Sub-Investigator: Leonard Bielory, MD         
Sponsors and Collaborators
Starx Research Center, LLC
Investigators
Principal Investigator: Jayesh Kanuga, MD Starx Research Center, LLC
  More Information

No publications provided

Responsible Party: Jayesh G. Kanuga, M.D., Medical Doctor, Starx Research Center, LLC
ClinicalTrials.gov Identifier: NCT01808768     History of Changes
Other Study ID Numbers: ID IIT- 000373
Study First Received: March 6, 2013
Last Updated: May 29, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Alcaftadine
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 14, 2014