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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 19, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 19, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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