Conjunctivitis, AllergicNCT02555761
Safety and Efficacy of Lastacaft® for the Prevention of Itching Associated With Allergic Conjunctivitis in Korea
An observational study of Conjunctivitis, Allergic, run by Allergan at 81 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Conjunctivitis, Allergic
- What is being tested?
- Alcaftadine Ophthalmic Solution 0.25%
- How many people
- 3,423 participants
- Where
- 81 sitesSouth Korea
- Study dates
- 19 Oct 2015to 19 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with itching associated with Allergic Conjunctivitis prescribed Lastacaft® as standard of care in clinical practice.
Who may be able to join
- -Patients with itching associated with allergic conjunctivitis.
Who cannot join
- -Patients with hypersensitivity to Lastacaft® or its components.
Trial locations and contacts
81 sites in 1 country.
81 sites in 1 country
South Korea81 sites
Seo-myeon St.Mary's Hospital
Busan, 47254
SeoMyeon St. Eye Clinic
Busan, 47254
Inje University Busan Paik Hospital
Busan, 47395
Soojung Eye Hospital
Busan, 48064
Inje University Haeundae Paik Hospital
Busan, 48108
Saint Mary Bright Eye Clinic
Busan, 48415
Daeyeon St.mary's Eye Center
Busan, 48492
Dong-A University Hospital
Busan, 49201
Pusan National University Hospital
Busan, 49241
Pusan National University Yangsan Hospital
Busan, 49241
Barun Sungmo Eye Clinic
Busan, 49247
chamjoeun Ophthalmic Clinic
Busan
Soonchunhyang University Cheonan Hospital
Chungcheongnam-do, 31151
Cheil eye hospital
Daegu, 41196
Keimyung University Dongsan Medical Center
Daegu, 41931
Kyoungpook national university hospital
Daegu, 41944
Daegu Nune Eye Hospital
Daegu, 42109
Saebom Eye Clinic
Daejeon, 34066
Jungbuwoorieye Clinic
Daejeon, 34914
Chonnam National University Hospital
Daejeon, 35015
Clean Eye clinic
Daejeon, 35209
Eye Love Eye Center
Daejeon, 35234
Konyang University Hospital
Daejeon, 35365
Chonnam National University Hospital
Daejoen, 35015
Konyang University Hospital
Daejoen, 35365
St. Mary's Eye center
Geyonggi-do, 11695
Eins Eye Clinic
Geyonsangnam-do, 51356
Happ Eye 21
Gwangju, 61062
Gwang Ju Eye Clinic
Gwangju, 61478
Bora Eye Clinic
Gwangju, 61964
Bora Eye Clinic
Gwangju, 62276
Myongji Hospital
Gyeonggi-do, 10475
Munsan Jeil Eye Clinic
Gyeonggi-do, 10824
Seoul Shinsegae Eye Center
Gyeonggi-do, 11695
Eagle Eye Center
Gyeonggi-do, 13591
Anyang Seoul Eye Clinic
Gyeonggi-do, 14064
Noon-Sarang Eye Hospital
Gyeonggi-do, 16849
Bright eye
Gyeonggi-do, 18600
Ansan Yonsei Eye Center
Gyeonggi-do
Yonsei Dream Eye Clinic
Gyeonggi-do
Bright Kim's Eye Clinic
Gyeongsangnam-do, 50621
Fatima ophthalmology
Gyeongsangnam-do, 51408
Gowoon eye clinic
Gyeongsangnam-do, 51436
Sungmo Eye Hospital
Haeundae-gu, 48064
Hangil Eye Hospital
Incheon, 05558
Hangil Eye Hospital
Incheon, 21388
Gachon University Gil Medical Center
Incheon, 21565
Renessance eye center
Incheon, 22134
Bupyung ST.Mary's eye clinic
Incheon, 48064
Pureun Eye Center
Jeollabuk-do, 54921
Pureun Eye Center
Jeollabuk-do, 5492
Onuri Eye Hospital
Jeollabuk-do, 54972
Seoul Eye Clinic
Jeollanam-do, 57643
National Health Insurance Service Ilsan Hospital
Kyounggi-do, 410719
Yonsei Woori Eye Clinic
Seoul, 01779
Gangnam ST. Mary's Eye Center
Seoul, 02538
Hplus Eye Center
Seoul, 02622
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
Saevit Eye Center
Seoul, 03779
Sinchon Yeonsei Eye Hospital
Seoul, 04101
Central seoul eye center
Seoul, 04427
Ian Eye Center
Seoul, 04527
Lee, Im-sun Eye Clinic
Seoul, 04596
Yonsei Eye Clinic
Seoul, 04715
Asan Medical Center
Seoul, 05505
See Samsung Eye Center
Seoul, 05558
Yoon Ho Eye Hospital
Seoul, 06017
Apgujeong Eye Center
Seoul, 06030
Joeunnun Vision Clinic
Seoul, 06134
Nune Eye Hospital
Seoul, 06198
GS eye clinic
Seoul, 06232
Lee Eye Institute
Seoul, 06292
Samsung medical center
Seoul, 06351
The catholic university of korea Seoul ST. Mary's Hospital
Seoul, 06591
Su Yonsei Eye Clinic
Seoul, 06611
Kim's Eye Hospital
Seoul, 07301
Bright Seoul Ophthalmology
Seoul, 08058
The Catholic Unoveristy of Korea, Seoul St Mary's Hospital
Seoul, 137701
Severance Hospital
Seoul, 37722
Park Chang Soo Eye Clinic
Seoul
About this study
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
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.
- Conditions
- Conjunctivitis, Allergic
- Being tested
- Alcaftadine Ophthalmic Solution 0.25%
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcaftadine Ophthalmic Solution 0.25%Drug
Also called Lastacaft®
Alcaftadine Ophthalmic Solution 0.25% (Lastacaft®) as prescribed as standard of care in clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Lastacaft® | One drop of Lastacaft® Ophthalmic Solution 0.25% (Alcaftadine) in each eye daily as prescribed as standard of care in clinical practice. Receives: Drug: Alcaftadine Ophthalmic Solution 0.25% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study start19 Oct 2015
- Primary completion19 Mar 2018
- Study completion19 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conjunctivitis, AllergicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,423 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yan Bai, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555761
- Sponsor's protocol ID
- 229666-007
- Status last verified
- Jul 2019
- First submitted
- 18 Sep 2015
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02555761
- Acronym / sponsor ID
- 229666-007
- Conditions
- Conjunctivitis, Allergic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,423 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2015 (actual)
- Primary completion
- 19 Mar 2018 (actual)
- Study completion
- 19 Mar 2018 (actual)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lastacaft® | – | Drug: Alcaftadine Ophthalmic Solution 0.25%One drop of Lastacaft® Ophthalmic Solution 0.25% (Alcaftadine) in each eye daily as prescribed as standard of care in clinical practice. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with itching associated with Allergic Conjunctivitis prescribed Lastacaft® as standard of care in clinical practice.
Key inclusion criteria (1 listed)
- -Patients with itching associated with allergic conjunctivitis.
Key exclusion criteria (1 listed)
- -Patients with hypersensitivity to Lastacaft® or its components.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcaftadine Ophthalmic Solution 0.25%Also: Lastacaft®Alcaftadine Ophthalmic Solution 0.25% (Lastacaft®) as prescribed as standard of care in clinical practice. | Drug | Lastacaft® |
Primary outcome
Number of Participants with Adverse Events
Time frame: 2 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Bai study director
Allergan
81 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conjunctivitis, Allergic, run by Allergan at 81 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (time frame: 2 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.