Clinical trial NCT02555761: Safety and Efficacy of Lastacaft® for the Prevention of Itching Associated With Allergic Conjunctivitis in Korea
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Conjunctivitis, Allergic
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-09-22
Enrollment: 3423
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with itching associated with Allergic Conjunctivitis prescribed Lastacaft® as standard of care in clinical practice.

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.


Eligibility criteria: Inclusion Criteria:

-Patients with itching associated with allergic conjunctivitis.

Exclusion Criteria:

-Patients with hypersensitivity to Lastacaft® or its components.

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 2 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Seo-myeon St.Mary's Hospital
city: Busan
country: Korea, Republic of
facility: SeoMyeon St. Eye Clinic
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Soojung Eye Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Saint Mary Bright Eye Clinic
city: Busan
country: Korea, Republic of
facility: Daeyeon St.mary's Eye Center
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Busan
country: Korea, Republic of
facility: Barun Sungmo Eye Clinic
city: Busan
country: Korea, Republic of
facility: chamjoeun Ophthalmic Clinic
city: Chungcheongnam-do
country: Korea, Republic of
facility: Soonchunhyang University Cheonan Hospital
city: Daegu
country: Korea, Republic of
facility: Cheil eye hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyoungpook national university hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Nune Eye Hospital
city: Daejeon
country: Korea, Republic of
facility: Saebom Eye Clinic
city: Daejeon
country: Korea, Republic of
facility: Jungbuwoorieye Clinic
city: Daejeon
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Clean Eye clinic
city: Daejeon
country: Korea, Republic of
facility: Eye Love Eye Center
city: Daejoen
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Daejoen
country: Korea, Republic of
facility: Konyang University Hospital
city: Daejon
country: Korea, Republic of
facility: Konyang University Hospital
city: Geyonggi-do
country: Korea, Republic of
facility: St. Mary's Eye center
city: Geyonsangnam-do
country: Korea, Republic of
facility: Eins Eye Clinic
city: Gwangju
country: Korea, Republic of
facility: Happ Eye 21
city: Gwangju
country: Korea, Republic of
facility: Gwang Ju Eye Clinic
city: Gwangju
country: Korea, Republic of
facility: Bora Eye Clinic
city: Gwangju
country: Korea, Republic of
facility: Bora Eye Clinic
city: Gyeonggi-do
country: Korea, Republic of
facility: Myongji Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Munsan Jeil Eye Clinic
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul Shinsegae Eye Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Eagle Eye Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Anyang Seoul Eye Clinic
city: Gyeonggi-do
country: Korea, Republic of
facility: Noon-Sarang Eye Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Bright eye
city: Gyeonggi-do
country: Korea, Republic of
facility: Ansan Yonsei Eye Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Yonsei Dream Eye Clinic
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Bright Kim's Eye Clinic
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Fatima ophthalmology
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Gowoon eye clinic
city: Haeundae-gu
country: Korea, Republic of
facility: Sungmo Eye Hospital
city: Incheon
country: Korea, Republic of
facility: Hangil Eye Hospital
city: Incheon
country: Korea, Republic of
facility: Hangil Eye Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Renessance eye center
city: Incheon
country: Korea, Republic of
facility: Bupyung ST.Mary's eye clinic
city: Jeollabuk-do
country: Korea, Republic of
facility: Pureun Eye Center
city: Jeollabuk-do
country: Korea, Republic of
facility: Pureun Eye Center
city: Jeollabuk-do
country: Korea, Republic of
facility: Onuri Eye Hospital
city: Jeollanam-do
country: Korea, Republic of
facility: Seoul Eye Clinic
city: Kyounggi-do
country: Korea, Republic of
facility: National Health Insurance Service Ilsan Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei Woori Eye Clinic
city: Seoul
country: Korea, Republic of
facility: Gangnam ST. Mary's Eye Center
city: Seoul
country: Korea, Republic of
facility: Hplus Eye Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Saevit Eye Center
city: Seoul
country: Korea, Republic of
facility: Sinchon Yeonsei Eye Hospital
city: Seoul
country: Korea, Republic of
facility: Central seoul eye center
city: Seoul
country: Korea, Republic of
facility: Ian Eye Center
city: Seoul
country: Korea, Republic of
facility: Lee, Im-sun Eye Clinic
city: Seoul
country: Korea, Republic of
facility: Yonsei Eye Clinic
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: See Samsung Eye Center
city: Seoul
country: Korea, Republic of
facility: Yoon Ho Eye Hospital
city: Seoul
country: Korea, Republic of
facility: Apgujeong Eye Center
city: Seoul
country: Korea, Republic of
facility: Joeunnun Vision Clinic
city: Seoul
country: Korea, Republic of
facility: Nune Eye Hospital
city: Seoul
country: Korea, Republic of
facility: GS eye clinic
city: Seoul
country: Korea, Republic of
facility: Lee Eye Institute
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
city: Seoul
country: Korea, Republic of
facility: The catholic university of korea Seoul ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Su Yonsei Eye Clinic
city: Seoul
country: Korea, Republic of
facility: Kim's Eye Hospital
city: Seoul
country: Korea, Republic of
facility: Bright Seoul Ophthalmology
city: Seoul
country: Korea, Republic of
facility: The Catholic Unoveristy of Korea, Seoul St Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Park Chang Soo Eye Clinic
Study officials:
affiliation: Allergan
name: Yan Bai
role: STUDY_DIRECTOR
References: