A Study to Evaluate the Duration of LASTACAFT® in Acute Allergic Conjunctivitis

Allergan127 enrolled

Overview

This study will evaluate the duration of action of LASTACAFT® and Pataday™ as compared to artificial tears (placebo) in the prevention of ocular itching associated with allergic conjunctivitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

127

Conditions

Conjunctivitis, Allergic

Interventions

alcaftadine 0.25% ophthalmic solutionDRUG

One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.

olopatadine 0.2% ophthalmic solutionDRUG

One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.

dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%DRUG

One drop of placebo instilled in each eye at Day 0 and Day 14.

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

Inclusion Criteria: * History of eye allergies within the past 24 months * Willing to not wear contact lenses at least 72 hours prior to the study start and during the study period Exclusion Criteria: * Current eye infection * Eye surgery within 3 months or vision correction surgery within 6 months * Any planned surgery during the study or 30 days after the study

Locations (1)

Unnamed facility

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16

Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3) at hour 16. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.

Time frame: Day 0 Hour 16

Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24

Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.

Time frame: Day 14 Hour 24

Secondary Outcomes

Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24

Conjunctival redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored conjunctival redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less conjunctival redness.

Time frame: Day 14 Hour 24

Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24

Ciliary redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored ciliary redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less ciliary redness.

Data from ClinicalTrials.gov

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