Study identification

PURI

https://redirect.ema.europa.eu/resource/27008

EU PAS number

EUPAS16675

Study ID

27008

Official title and acronym

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

DARWIN EU® study

No

Study countries

Korea, Democratic People's Republic of

Study description

Objective: To evaluate the safety and effectiveness of Lastacaft® for the prevention of itching associated with allergic conjunctivitis through active surveillance under routine clinical practice. The specific aims are to report on the: 1. Serious adverse events or adverse drug reactions 2. Unexpected adverse drug reactions that are not listed in the precautions for use in the product label (hereafter referred to as unexpected adverse drug reactions) 3. Known adverse drug reactions 4. Non-serious adverse events 5. Effectiveness of Lastacaft as measured by a change from baseline in the patient’s assessment of itching associated with allergic conjunctivitis The study will sequentially enroll at least 3,000 Korean patients at participating sites who are treated with Lastacaft Ophthalmic Solution 0.25% (hereafter referred to as Lastacaft) at the labeled dose, as per clinical practice. Only those patients who have consented to the study and who have signed the private information protection act form or ICF will be included in the study. Safety information and effectiveness, as assessed by the patient, will be collected during any in-office visit within approximately 2 weeks of starting treatment with Lastacaft. Safety information and the patient’s assessment of effectiveness may also be collected via telephone contact if patients do not have an in-office visit during this period. Study will be completed within after product approval or when at least 3,000 patients have completed the study. Periodic and final reports will be sent to MFDS according to the schedule per regulation

Study status

Finalised
Research institutions and networks

Institutions

DreamCIS
First published:
01/02/2024
Institution

Contact details

Anita Verga

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Allergan
Study protocol
Initial protocol

Protocol 229666-007 PMS Korea Amd 2 FINAL 28Aug2015 D1

English (399.6 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Non-EU RMP only