Ocular Allergy Treatment Practical Impact Trial

Phase 4

• Conditions: Allergic Conjunctivitis; Rhinoconjunctivitis
• Interventions: Drug: Alcaftadine

• Registration Number: NCT01808768
• Lead Sponsor: Starx Research Center, LLC

Brief Summary

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

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

Study Timeline

• Status Verified: 2013-03
• Study First Submitted: 2013-03-06
• Study First Submitted QC: 2013-03-07
• Study First Posted: 2013-03-11
• Study Start: 2013-04
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-30
• Primary Completion: 2013-10
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

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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) -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alcaftadine	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

Primary Outcome Measures

Name	Time	Method
Quality of Life- Eye Allergy Patient Impact Questionnaire	4 months

Secondary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index Pollen Count correlation of symptoms	6 months

Trial Locations

Locations (2)

STARx; 🇺🇸 Springfield, New Jersey, United States

STARx Research Center; 🇺🇸 Edison, New Jersey, United States