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

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT02555761
Collaborator
(none)
3,423
Enrollment
81
Locations
29
Actual Duration (Months)
42.3
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Alcaftadine Ophthalmic Solution 0.25%

Study Design

Study Type:
Observational
Actual Enrollment :
3423 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Oct 19, 2015
Actual Primary Completion Date :
Mar 19, 2018
Actual Study Completion Date :
Mar 19, 2018

Arms and Interventions

Arm 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®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Adverse Events [2 Weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    -Patients with itching associated with allergic conjunctivitis.

    Exclusion Criteria:

    -Patients with hypersensitivity to Lastacaft® or its components.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seo-myeon St.Mary's Hospital Busan Korea, Republic of 47254
    2 SeoMyeon St. Eye Clinic Busan Korea, Republic of 47254
    3 Inje University Busan Paik Hospital Busan Korea, Republic of 47395
    4 Soojung Eye Hospital Busan Korea, Republic of 48064
    5 Inje University Haeundae Paik Hospital Busan Korea, Republic of 48108
    6 Saint Mary Bright Eye Clinic Busan Korea, Republic of 48415
    7 Daeyeon St.mary's Eye Center Busan Korea, Republic of 48492
    8 Dong-A University Hospital Busan Korea, Republic of 49201
    9 Pusan National University Hospital Busan Korea, Republic of 49241
    10 Pusan National University Yangsan Hospital Busan Korea, Republic of 49241
    11 Barun Sungmo Eye Clinic Busan Korea, Republic of 49247
    12 chamjoeun Ophthalmic Clinic Busan Korea, Republic of
    13 Soonchunhyang University Cheonan Hospital Chungcheongnam-do Korea, Republic of 31151
    14 Cheil eye hospital Daegu Korea, Republic of 41196
    15 Keimyung University Dongsan Medical Center Daegu Korea, Republic of 41931
    16 Kyoungpook national university hospital Daegu Korea, Republic of 41944
    17 Daegu Nune Eye Hospital Daegu Korea, Republic of 42109
    18 Saebom Eye Clinic Daejeon Korea, Republic of 34066
    19 Jungbuwoorieye Clinic Daejeon Korea, Republic of 34914
    20 Chonnam National University Hospital Daejeon Korea, Republic of 35015
    21 Clean Eye clinic Daejeon Korea, Republic of 35209
    22 Eye Love Eye Center Daejeon Korea, Republic of 35234
    23 Chonnam National University Hospital Daejoen Korea, Republic of 35015
    24 Konyang University Hospital Daejoen Korea, Republic of 35365
    25 Konyang University Hospital Daejon Korea, Republic of 35365
    26 St. Mary's Eye center Geyonggi-do Korea, Republic of 11695
    27 Eins Eye Clinic Geyonsangnam-do Korea, Republic of 51356
    28 Happ Eye 21 Gwangju Korea, Republic of 61062
    29 Gwang Ju Eye Clinic Gwangju Korea, Republic of 61478
    30 Bora Eye Clinic Gwangju Korea, Republic of 61964
    31 Bora Eye Clinic Gwangju Korea, Republic of 62276
    32 Myongji Hospital Gyeonggi-do Korea, Republic of 10475
    33 Munsan Jeil Eye Clinic Gyeonggi-do Korea, Republic of 10824
    34 Seoul Shinsegae Eye Center Gyeonggi-do Korea, Republic of 11695
    35 Eagle Eye Center Gyeonggi-do Korea, Republic of 13591
    36 Anyang Seoul Eye Clinic Gyeonggi-do Korea, Republic of 14064
    37 Noon-Sarang Eye Hospital Gyeonggi-do Korea, Republic of 16849
    38 Bright eye Gyeonggi-do Korea, Republic of 18600
    39 Ansan Yonsei Eye Center Gyeonggi-do Korea, Republic of
    40 Yonsei Dream Eye Clinic Gyeonggi-do Korea, Republic of
    41 Bright Kim's Eye Clinic Gyeongsangnam-do Korea, Republic of 50621
    42 Fatima ophthalmology Gyeongsangnam-do Korea, Republic of 51408
    43 Gowoon eye clinic Gyeongsangnam-do Korea, Republic of 51436
    44 Sungmo Eye Hospital Haeundae-gu Korea, Republic of 48064
    45 Hangil Eye Hospital Incheon Korea, Republic of 05558
    46 Hangil Eye Hospital Incheon Korea, Republic of 21388
    47 Gachon University Gil Medical Center Incheon Korea, Republic of 21565
    48 Renessance eye center Incheon Korea, Republic of 22134
    49 Bupyung ST.Mary's eye clinic Incheon Korea, Republic of 48064
    50 Pureun Eye Center Jeollabuk-do Korea, Republic of 54921
    51 Pureun Eye Center Jeollabuk-do Korea, Republic of 5492
    52 Onuri Eye Hospital Jeollabuk-do Korea, Republic of 54972
    53 Seoul Eye Clinic Jeollanam-do Korea, Republic of 57643
    54 National Health Insurance Service Ilsan Hospital Kyounggi-do Korea, Republic of 410719
    55 Yonsei Woori Eye Clinic Seoul Korea, Republic of 01779
    56 Gangnam ST. Mary's Eye Center Seoul Korea, Republic of 02538
    57 Hplus Eye Center Seoul Korea, Republic of 02622
    58 Korea University Anam Hospital Seoul Korea, Republic of 02841
    59 Seoul National University Hospital Seoul Korea, Republic of 03080
    60 Saevit Eye Center Seoul Korea, Republic of 03779
    61 Sinchon Yeonsei Eye Hospital Seoul Korea, Republic of 04101
    62 Central seoul eye center Seoul Korea, Republic of 04427
    63 Ian Eye Center Seoul Korea, Republic of 04527
    64 Lee, Im-sun Eye Clinic Seoul Korea, Republic of 04596
    65 Yonsei Eye Clinic Seoul Korea, Republic of 04715
    66 Asan Medical Center Seoul Korea, Republic of 05505
    67 See Samsung Eye Center Seoul Korea, Republic of 05558
    68 Yoon Ho Eye Hospital Seoul Korea, Republic of 06017
    69 Apgujeong Eye Center Seoul Korea, Republic of 06030
    70 Joeunnun Vision Clinic Seoul Korea, Republic of 06134
    71 Nune Eye Hospital Seoul Korea, Republic of 06198
    72 GS eye clinic Seoul Korea, Republic of 06232
    73 Lee Eye Institute Seoul Korea, Republic of 06292
    74 Samsung medical center Seoul Korea, Republic of 06351
    75 The catholic university of korea Seoul ST. Mary's Hospital Seoul Korea, Republic of 06591
    76 Su Yonsei Eye Clinic Seoul Korea, Republic of 06611
    77 Kim's Eye Hospital Seoul Korea, Republic of 07301
    78 Bright Seoul Ophthalmology Seoul Korea, Republic of 08058
    79 The Catholic Unoveristy of Korea, Seoul St Mary's Hospital Seoul Korea, Republic of 137701
    80 Severance Hospital Seoul Korea, Republic of 37722
    81 Park Chang Soo Eye Clinic Seoul Korea, Republic of

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: Yan Bai, Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT02555761
    Other Study ID Numbers:
    • 229666-007
    First Posted:
    Sep 22, 2015
    Last Update Posted:
    Jul 5, 2019
    Last Verified:
    Jul 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Conjunctivitis
    Conjunctivitis, Allergic
    Ophthalmic Solutions
    Alcaftadine

    Study Results

    No Results Posted as of Jul 5, 2019