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

NCT ID: NCT01470118

Last Updated: 2013-02-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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® (alcaftadine 0.25%)

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

Group Type ACTIVE_COMPARATOR

alcaftadine 0.25% ophthalmic solution

Intervention Type DRUG

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

Pataday™ (olopatadine 0.2%)

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

Group Type ACTIVE_COMPARATOR

olopatadine 0.2% ophthalmic solution

Intervention Type DRUG

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

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

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

Group Type PLACEBO_COMPARATOR

dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%

Intervention Type DRUG

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

Interventions

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alcaftadine 0.25% ophthalmic solution

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

Intervention Type DRUG

olopatadine 0.2% ophthalmic solution

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

Intervention Type DRUG

dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%

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

Intervention Type DRUG

Other Intervention Names

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LASTACAFT® Pataday™ Tears Naturale® II Artificial Tears

Eligibility Criteria

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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
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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Philadelphia, Pennsylvania, 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-011-001

Identifier Type: -

Identifier Source: org_study_id

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