NCT02555761

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,423

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

Geographic Reach
1 country

81 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

October 19, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2018

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

2.4 years

First QC Date

September 18, 2015

Last Update Submit

July 2, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse Events

    2 Weeks

Study Arms (1)

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%

Interventions

Alcaftadine Ophthalmic Solution 0.25% (Lastacaft®) as prescribed as standard of care in clinical practice.

Also known as: Lastacaft®
Lastacaft®

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patients with itching associated with allergic conjunctivitis.

You may not qualify if:

  • Patients with hypersensitivity to Lastacaft® or its components.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (81)

Seo-myeon St.Mary's Hospital

Busan, 47254, South Korea

Location

SeoMyeon St. Eye Clinic

Busan, 47254, South Korea

Location

Inje University Busan Paik Hospital

Busan, 47395, South Korea

Location

Soojung Eye Hospital

Busan, 48064, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Saint Mary Bright Eye Clinic

Busan, 48415, South Korea

Location

Daeyeon St.mary's Eye Center

Busan, 48492, South Korea

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Pusan National University Yangsan Hospital

Busan, 49241, South Korea

Location

Barun Sungmo Eye Clinic

Busan, 49247, South Korea

Location

chamjoeun Ophthalmic Clinic

Busan, South Korea

Location

Soonchunhyang University Cheonan Hospital

Chungcheongnam-do, 31151, South Korea

Location

Cheil eye hospital

Daegu, 41196, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 41931, South Korea

Location

Kyoungpook national university hospital

Daegu, 41944, South Korea

Location

Daegu Nune Eye Hospital

Daegu, 42109, South Korea

Location

Saebom Eye Clinic

Daejeon, 34066, South Korea

Location

Jungbuwoorieye Clinic

Daejeon, 34914, South Korea

Location

Chonnam National University Hospital

Daejeon, 35015, South Korea

Location

Clean Eye clinic

Daejeon, 35209, South Korea

Location

Eye Love Eye Center

Daejeon, 35234, South Korea

Location

Konyang University Hospital

Daejeon, 35365, South Korea

Location

Chonnam National University Hospital

Daejoen, 35015, South Korea

Location

Konyang University Hospital

Daejoen, 35365, South Korea

Location

St. Mary's Eye center

Geyonggi-do, 11695, South Korea

Location

Eins Eye Clinic

Geyonsangnam-do, 51356, South Korea

Location

Happ Eye 21

Gwangju, 61062, South Korea

Location

Gwang Ju Eye Clinic

Gwangju, 61478, South Korea

Location

Bora Eye Clinic

Gwangju, 61964, South Korea

Location

Bora Eye Clinic

Gwangju, 62276, South Korea

Location

Myongji Hospital

Gyeonggi-do, 10475, South Korea

Location

Munsan Jeil Eye Clinic

Gyeonggi-do, 10824, South Korea

Location

Seoul Shinsegae Eye Center

Gyeonggi-do, 11695, South Korea

Location

Eagle Eye Center

Gyeonggi-do, 13591, South Korea

Location

Anyang Seoul Eye Clinic

Gyeonggi-do, 14064, South Korea

Location

Noon-Sarang Eye Hospital

Gyeonggi-do, 16849, South Korea

Location

Bright eye

Gyeonggi-do, 18600, South Korea

Location

Ansan Yonsei Eye Center

Gyeonggi-do, South Korea

Location

Yonsei Dream Eye Clinic

Gyeonggi-do, South Korea

Location

Bright Kim's Eye Clinic

Gyeongsangnam-do, 50621, South Korea

Location

Fatima ophthalmology

Gyeongsangnam-do, 51408, South Korea

Location

Gowoon eye clinic

Gyeongsangnam-do, 51436, South Korea

Location

Sungmo Eye Hospital

Haeundae-gu, 48064, South Korea

Location

Hangil Eye Hospital

Incheon, 05558, South Korea

Location

Hangil Eye Hospital

Incheon, 21388, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Renessance eye center

Incheon, 22134, South Korea

Location

Bupyung ST.Mary's eye clinic

Incheon, 48064, South Korea

Location

Pureun Eye Center

Jeollabuk-do, 54921, South Korea

Location

Pureun Eye Center

Jeollabuk-do, 5492, South Korea

Location

Onuri Eye Hospital

Jeollabuk-do, 54972, South Korea

Location

Seoul Eye Clinic

Jeollanam-do, 57643, South Korea

Location

National Health Insurance Service Ilsan Hospital

Kyounggi-do, 410719, South Korea

Location

Yonsei Woori Eye Clinic

Seoul, 01779, South Korea

Location

Gangnam ST. Mary's Eye Center

Seoul, 02538, South Korea

Location

Hplus Eye Center

Seoul, 02622, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Saevit Eye Center

Seoul, 03779, South Korea

Location

Sinchon Yeonsei Eye Hospital

Seoul, 04101, South Korea

Location

Central seoul eye center

Seoul, 04427, South Korea

Location

Ian Eye Center

Seoul, 04527, South Korea

Location

Lee, Im-sun Eye Clinic

Seoul, 04596, South Korea

Location

Yonsei Eye Clinic

Seoul, 04715, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

See Samsung Eye Center

Seoul, 05558, South Korea

Location

Yoon Ho Eye Hospital

Seoul, 06017, South Korea

Location

Apgujeong Eye Center

Seoul, 06030, South Korea

Location

Joeunnun Vision Clinic

Seoul, 06134, South Korea

Location

Nune Eye Hospital

Seoul, 06198, South Korea

Location

GS eye clinic

Seoul, 06232, South Korea

Location

Lee Eye Institute

Seoul, 06292, South Korea

Location

Samsung medical center

Seoul, 06351, South Korea

Location

The catholic university of korea Seoul ST. Mary's Hospital

Seoul, 06591, South Korea

Location

Su Yonsei Eye Clinic

Seoul, 06611, South Korea

Location

Kim's Eye Hospital

Seoul, 07301, South Korea

Location

Bright Seoul Ophthalmology

Seoul, 08058, South Korea

Location

The Catholic Unoveristy of Korea, Seoul St Mary's Hospital

Seoul, 137701, South Korea

Location

Severance Hospital

Seoul, 37722, South Korea

Location

Park Chang Soo Eye Clinic

Seoul, South Korea

Location

Related Links

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

alcaftadine

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Yan Bai

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2015

First Posted

September 22, 2015

Study Start

October 19, 2015

Primary Completion

March 19, 2018

Study Completion

March 19, 2018

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations