Recruiting

Ocular Allergy

Sponsor:

Starx Research Center, LLC

Code:

NCT01808768

Conditions

Allergic Conjunctivitis

Rhinoconjunctivitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Alcaftadine

Study Details

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.

Conditions

Allergic Conjunctivitis

Rhinoconjunctivitis

Study ID

NCT01808768

Start date

Apr, 2013

Status verified date

Mar, 2013

Completion date

Nov, 2013

Anticipated

Primary completion date

Oct, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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) -

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

Interventions

Alcaftadine

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

Primary outcome measure

  • Quality of Life- Eye Allergy Patient Impact Questionnaire [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Locations

STARx Research Center

Recruiting

Edison, New Jersey, United States, 08820

Contacts

Principal Investigator:

Jayesh Kanuga, MD

STARx

Recruiting

Springfield, New Jersey, United States, 07081

Contacts

More Information

Sponsor

Starx Research Center, LLC

Last update posted

May 30, 2013

Last verified

Mar, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Starx Research Center, LLC on 2013-05-30.