Ocular Allergy Treatment Practical Impact Trial

Allergic Conjunctivitis Clinical Trial

— (OAT-PIT)  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01808768
• Other study ID #: ID IIT- 000373
• Status: Unknown status
• Phase: Phase 4
• First received: March 6, 2013
• Last updated: May 29, 2013
• Start date: April 2013
• Est. completion date: November 2013

Study information

• Verified date: March 2013
• Source: Starx Research Center, LLC
• Contact: Jayesh Kanuga, MD
• Phone: 732-906-1747
• Email: jkanuga[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 50
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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) -

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic
• Rhinoconjunctivitis

Intervention

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

Locations

Country	Name	City	State
United States	STARx Research Center	Edison	New Jersey
United States	STARx	Springfield	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Starx Research Center, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life- Eye Allergy Patient Impact Questionnaire		4 months
Secondary	Ocular Surface Disease Index Pollen Count correlation of symptoms		6 months