Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2019-11-28
2022-12-30
Brief Summary
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Detailed Description
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The recruitment period will be over 12-18 months to enroll all suitable patients. The total duration of prophylaxis will be for 1 year. After completion of the period of prophylaxis, the patients will be followed up as a non-study patient as clinically indicated.
Forty subjects, undergoing allo-HSCT, will be recruited from the Singapore National Eye Centre upon referral from the Department of Hematology, Singapore General Hospital and followed up at least 5 times over a period of 12 months at the Singapore Eye Research Institute.
The images of the subject eyes will be recorded and stored electronically. These images (corneal fluorescein staining score, Lipiview, meibography, conjunctival redness, tear stability assessment) will be used in the analysis of outcome measures. The Lipiview result is in video format.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Single arm
Ikervis (cyclosporine 0.1%), emulsion, one drop into both eyes, once at night.
Cyclosporine Ophthalmic
Prospective interventional study (single arm)
Interventions
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Cyclosporine Ophthalmic
Prospective interventional study (single arm)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to give informed consent
Exclusion Criteria
* Unable to complete the follow up
13 Years
95 Years
ALL
No
Sponsors
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Singapore Eye Research Institute
OTHER
Responsible Party
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Lim Li
Senior Consultant, Department of Corneal & External Eye Disease, Refractive surgery, Cataract & Comprehensive Ophthalmology, Adj Clinical Investigator, Adj A/Professor
Principal Investigators
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Li Lim
Role: PRINCIPAL_INVESTIGATOR
Senior Consultant
Locations
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Singapore Eye Research Institute
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Li Lim
Role: primary
References
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Tong L, Lim EWL, Yeo SWJ, Hou A, Linn YC, Ho A, Than H, Quek JKS, Hwang WYK, Lim FLWI, Lim L. Conjunctival T Cell Profile in Allogeneic Hematopoietic Stem Cell Transplant Patients after Instilling Topical Cyclosporine-A 0.1% Cationic Emulsion. Ophthalmol Ther. 2023 Jun;12(3):1547-1567. doi: 10.1007/s40123-023-00686-0. Epub 2023 Mar 1.
Other Identifiers
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R1641/38/2019
Identifier Type: -
Identifier Source: org_study_id