A Study to Evaluate the Efficacy of Lastacaft® Compared to Pataday™ and Placebo in Patients With Acute Allergic Conjunctivitis

NCT ID: NCT01732757

Last Updated: 2014-01-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2012-12-31

Brief Summary

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This study will evaluate the efficacy of Lastacaft® (Alcaftadine 0.25%) and Pataday™ (Olopatadine 0.2%) as compared to each other and to placebo in the prevention of ocular itching associated with allergic conjunctivitis.

Detailed Description

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Conditions

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Conjunctivitis, Allergic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lastacaft®

One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.

Group Type ACTIVE_COMPARATOR

Alcaftadine 0.25%

Intervention Type DRUG

One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.

Pataday™

One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.

Group Type ACTIVE_COMPARATOR

Olopatadine 0.2%

Intervention Type DRUG

One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.

Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)

One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.

Group Type PLACEBO_COMPARATOR

dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%

Intervention Type DRUG

One drop of placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.

Interventions

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Alcaftadine 0.25%

One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.

Intervention Type DRUG

Olopatadine 0.2%

One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.

Intervention Type DRUG

dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%

One drop of placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.

Intervention Type DRUG

Other Intervention Names

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Lastacaft® Pataday™ Tears Naturale II

Eligibility Criteria

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Inclusion Criteria

* History of ocular allergies within the past 24 months.
* Able to avoid wearing contact lenses for at least 72 hours prior to and during the study trial period.

Exclusion Criteria

* Any presence of active ocular infection or history of an ocular herpetic infection.
* Ocular surgery within 3 months prior to the first visit or refractive surgery within the past 6 months.
* Have any planned surgery during the study or 30 days after the study.
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Memphis, Tennessee, United States

Site Status

Countries

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United States

References

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McLaurin EB, Marsico NP, Ackerman SL, Ciolino JB, Williams JM, Villanueva L, Hollander DA. Ocular itch relief with alcaftadine 0.25% versus olopatadine 0.2% in allergic conjunctivitis: pooled analysis of two multicenter randomized clinical trials. Adv Ther. 2014 Oct;31(10):1059-71. doi: 10.1007/s12325-014-0155-3. Epub 2014 Sep 27.

Reference Type DERIVED
PMID: 25260889 (View on PubMed)

Other Identifiers

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GMA-LAS-12-023

Identifier Type: -

Identifier Source: org_study_id

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