Ocular Allergy Treatment Practical Impact Trial ((OAT-PIT))
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2013 by Starx Research Center, LLC.
Recruitment status was Recruiting
Information provided by (Responsible Party):
Jayesh G. Kanuga, M.D., Starx Research Center, LLC
First received: March 6, 2013
Last updated: May 29, 2013
Last verified: March 2013
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.
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||To Assess the Impact of Ocular Allergy Treatment on Patients Using an Opthalmic Agent (or no Treatment) Versus Alcaftadine(Lastacaft™)
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||October 2013 (Final data collection date for primary outcome measure)
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
Alcaftadine 0.25% one dorp each eye daily for 1-2 weeks.
Other Name: Lastacaft
To assess the impact of ocular allergy treatment on patients using an ophthalmic agent (or no treatment) versus alcaftadine(Lastacaft™)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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) -
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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
|STARx Research Center
|Edison, New Jersey, United States, 08820 |
|Contact: Erika Julca, lpn,crc 732-906-1747 firstname.lastname@example.org |
|Contact: June Pepe, lpn, ccrc 973-912-9817 email@example.com |
|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 |
|Contact: Leonard Bielory, MD 973-912-9817 DrLBielory@gmail.com |
|Sub-Investigator: Leonard Bielory, MD |
Starx Research Center, LLC
||Jayesh Kanuga, MD
||Starx Research Center, LLC
No publications provided
||Jayesh G. Kanuga, M.D., Medical Doctor, Starx Research Center, LLC
History of Changes
|Other Study ID Numbers:
||ID IIT- 000373
|Study First Received:
||March 6, 2013
||May 29, 2013
||United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 29, 2015
Immune System Diseases
Histamine H1 Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs