Suspended

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

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What is being tested

Alcaftadine

Drug
Who is being recruted

Conjunctival Diseases+4

+ Conjunctivitis

+ Eye Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorStarx Research Center, LLC
Study ContactJayesh Kanuga, MDMore contacts
Last updated: May 30, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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

NCT01808768
Principal SponsorStarx Research Center, LLC
Study ContactJayesh Kanuga, MDMore contacts
Last updated: May 30, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Conjunctival DiseasesConjunctivitisEye DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesConjunctivitis, Allergic

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) -

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

STARx Research Center

Edison, United StatesOpen STARx Research Center in Google Maps
Recruiting

STARx

Springfield, United States
Suspended2 Study Centers