Ocular Allergy Treatment Practical Impact Trial

NCT ID: NCT01808768

Last Updated: 2013-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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

Conditions

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Allergic Conjunctivitis Rhinoconjunctivitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Alcaftadine

Intervention Type DRUG

Alcaftadine 0.25% one dorp each eye daily for 1-2 weeks.

Interventions

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Alcaftadine

Alcaftadine 0.25% one dorp each eye daily for 1-2 weeks.

Intervention Type DRUG

Other Intervention Names

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Lastacaft

Eligibility Criteria

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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) -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Starx Research Center, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Jayesh G. Kanuga, M.D.

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jayesh Kanuga, MD

Role: PRINCIPAL_INVESTIGATOR

Starx Research Center, LLC

Locations

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STARx Research Center

Edison, New Jersey, United States

Site Status RECRUITING

STARx

Springfield, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jayesh Kanuga, MD

Role: CONTACT

732-906-1747

Erika Julca, LPN,CRC

Role: CONTACT

732-906-1747

Facility Contacts

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Erika Julca, lpn,crc

Role: primary

732-906-1747

June Pepe, lpn, ccrc

Role: backup

973-912-9817

Leonard Bielory, MD

Role: primary

973-912-9817

Other Identifiers

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ID IIT- 000373

Identifier Type: -

Identifier Source: org_study_id

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