Ocular Allergy Treatment Practical Impact Trial ((OAT-PIT))

Starx Research Center

Status and phase: Unknown; Phase 4

Conditions: Rhinoconjunctivitis; Allergic Conjunctivitis

Treatments: Drug: Alcaftadine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01808768

ID IIT- 000373

Details and patient eligibility

About

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.

Full description

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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) -

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Alcaftadine

Experimental group

Description:

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

Treatment:

Drug: Alcaftadine