Safety and Efficacy of Lastacaft® for the Prevention of Itching Associated With Allergic Conjunctivitis in Korea

July 2, 2019 updated by: Allergan

Evaluation of the Safety and Effectiveness of Lastacaft® Ophthalmic Solution 0.25% (Alcaftadine) for the Prevention of Itching Associated With Allergic Conjunctivitis: A Postmarketing Surveillance Study in Korea

This post-marketing surveillance study will assess the safety and efficacy of Lastacaft® Opthalmic Solution 0.25% (Alcaftadine) for the prevention of itching associated with Allergic Conjunctivitis as prescribed as standard of care in clinical practice in Korea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3423

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 48108
        • Inje University Haeundae Paik Hospital
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital
      • Busan, Korea, Republic of, 47254
        • Seo-myeon St.Mary's Hospital
      • Busan, Korea, Republic of, 47254
        • SeoMyeon St. Eye Clinic
      • Busan, Korea, Republic of, 47395
        • Inje University Busan Paik Hospital
      • Busan, Korea, Republic of, 48064
        • Soojung Eye Hospital
      • Busan, Korea, Republic of, 48415
        • Saint Mary Bright Eye Clinic
      • Busan, Korea, Republic of, 48492
        • Daeyeon St.mary's Eye Center
      • Busan, Korea, Republic of, 49241
        • Pusan National University Yangsan Hospital
      • Busan, Korea, Republic of, 49247
        • Barun Sungmo Eye Clinic
      • Busan, Korea, Republic of
        • chamjoeun Ophthalmic Clinic
      • Chungcheongnam-do, Korea, Republic of, 31151
        • Soonchunhyang University Cheonan Hospital
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Medical Center
      • Daegu, Korea, Republic of, 41196
        • Cheil eye hospital
      • Daegu, Korea, Republic of, 41944
        • Kyoungpook National University Hospital
      • Daegu, Korea, Republic of, 42109
        • Daegu Nune Eye Hospital
      • Daejeon, Korea, Republic of, 34066
        • Saebom Eye Clinic
      • Daejeon, Korea, Republic of, 34914
        • Jungbuwoorieye Clinic
      • Daejeon, Korea, Republic of, 35015
        • Chonnam National University Hospital
      • Daejeon, Korea, Republic of, 35209
        • Clean Eye clinic
      • Daejeon, Korea, Republic of, 35234
        • Eye Love Eye Center
      • Daejoen, Korea, Republic of, 35015
        • Chonnam National University Hospital
      • Daejoen, Korea, Republic of, 35365
        • Konyang University Hospital
      • Daejon, Korea, Republic of, 35365
        • Konyang University Hospital
      • Geyonggi-do, Korea, Republic of, 11695
        • St. Mary's Eye center
      • Geyonsangnam-do, Korea, Republic of, 51356
        • Eins Eye Clinic
      • Gwangju, Korea, Republic of, 61062
        • Happ Eye 21
      • Gwangju, Korea, Republic of, 61478
        • Gwang Ju Eye Clinic
      • Gwangju, Korea, Republic of, 61964
        • Bora Eye Clinic
      • Gwangju, Korea, Republic of, 62276
        • Bora Eye Clinic
      • Gyeonggi-do, Korea, Republic of, 10475
        • Myongji Hospital
      • Gyeonggi-do, Korea, Republic of, 10824
        • Munsan Jeil Eye Clinic
      • Gyeonggi-do, Korea, Republic of, 11695
        • Seoul Shinsegae Eye Center
      • Gyeonggi-do, Korea, Republic of, 13591
        • Eagle Eye Center
      • Gyeonggi-do, Korea, Republic of, 14064
        • Anyang Seoul Eye Clinic
      • Gyeonggi-do, Korea, Republic of, 16849
        • Noon-Sarang Eye Hospital
      • Gyeonggi-do, Korea, Republic of, 18600
        • Bright eye
      • Gyeonggi-do, Korea, Republic of
        • Ansan Yonsei Eye Center
      • Gyeonggi-do, Korea, Republic of
        • Yonsei Dream Eye Clinic
      • Gyeongsangnam-do, Korea, Republic of, 50621
        • Bright Kim's Eye Clinic
      • Gyeongsangnam-do, Korea, Republic of, 51408
        • Fatima ophthalmology
      • Gyeongsangnam-do, Korea, Republic of, 51436
        • Gowoon eye clinic
      • Haeundae-gu, Korea, Republic of, 48064
        • Sungmo Eye Hospital
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Incheon, Korea, Republic of, 05558
        • HanGil Eye Hospital
      • Incheon, Korea, Republic of, 21388
        • HanGil Eye Hospital
      • Incheon, Korea, Republic of, 22134
        • Renessance eye center
      • Incheon, Korea, Republic of, 48064
        • Bupyung ST.Mary's eye clinic
      • Jeollabuk-do, Korea, Republic of, 54921
        • Pureun Eye Center
      • Jeollabuk-do, Korea, Republic of, 5492
        • Pureun Eye Center
      • Jeollabuk-do, Korea, Republic of, 54972
        • Onuri Eye Hospital
      • Jeollanam-do, Korea, Republic of, 57643
        • Seoul Eye Clinic
      • Kyounggi-do, Korea, Republic of, 410719
        • National Health Insurance Service Ilsan Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea Seoul St. Mary'S Hospital
      • Seoul, Korea, Republic of, 01779
        • Yonsei Woori Eye Clinic
      • Seoul, Korea, Republic of, 02538
        • Gangnam ST. Mary's Eye Center
      • Seoul, Korea, Republic of, 02622
        • Hplus Eye Center
      • Seoul, Korea, Republic of, 03779
        • Saevit Eye Center
      • Seoul, Korea, Republic of, 04101
        • Sinchon Yeonsei Eye Hospital
      • Seoul, Korea, Republic of, 04427
        • Central seoul eye center
      • Seoul, Korea, Republic of, 04527
        • Ian Eye Center
      • Seoul, Korea, Republic of, 04596
        • Lee, Im-sun Eye Clinic
      • Seoul, Korea, Republic of, 04715
        • Yonsei Eye Clinic
      • Seoul, Korea, Republic of, 05558
        • See Samsung Eye Center
      • Seoul, Korea, Republic of, 06017
        • Yoon Ho Eye Hospital
      • Seoul, Korea, Republic of, 06030
        • Apgujeong Eye Center
      • Seoul, Korea, Republic of, 06134
        • Joeunnun Vision Clinic
      • Seoul, Korea, Republic of, 06198
        • Nune Eye Hospital
      • Seoul, Korea, Republic of, 06232
        • GS eye clinic
      • Seoul, Korea, Republic of, 06292
        • Lee Eye Institute
      • Seoul, Korea, Republic of, 06611
        • SU Yonsei Eye Clinic
      • Seoul, Korea, Republic of, 07301
        • Kim's Eye Hospital
      • Seoul, Korea, Republic of, 08058
        • Bright Seoul Ophthalmology
      • Seoul, Korea, Republic of, 137701
        • The Catholic Unoveristy of Korea, Seoul St Mary's Hospital
      • Seoul, Korea, Republic of, 37722
        • Severance Hospital
      • Seoul, Korea, Republic of
        • Park Chang Soo Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with itching associated with Allergic Conjunctivitis prescribed Lastacaft® as standard of care in clinical practice.

Description

Inclusion Criteria:

-Patients with itching associated with allergic conjunctivitis.

Exclusion Criteria:

-Patients with hypersensitivity to Lastacaft® or its components.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lastacaft®
One drop of Lastacaft® Ophthalmic Solution 0.25% (Alcaftadine) in each eye daily as prescribed as standard of care in clinical practice.
Drug: Alcaftadine Ophthalmic Solution 0.25%
Alcaftadine Ophthalmic Solution 0.25% (Lastacaft®) as prescribed as standard of care in clinical practice.
Other Names:
  • Lastacaft®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events
Time Frame: 2 Weeks
2 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Yan Bai, Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2015

Primary Completion (Actual)

March 19, 2018

Study Completion (Actual)

March 19, 2018

Study Registration Dates

First Submitted

September 18, 2015

First Submitted That Met QC Criteria

September 18, 2015

First Posted (Estimate)

September 22, 2015

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 229666-007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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