Ikervis for DED Due to GVHD Post Allo-HSCT

NCT ID: NCT04636918

Last Updated: 2020-11-19

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-28

Study Completion Date

2022-12-30

Brief Summary

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Dry eye disease (DED) is a common sequelae of graft versus host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Since Ikervis is reported to be a safe and efficacious treatment of DED associated with chronic GVHD, our study would like to study the efficacy of prophlactic Ikervis in preventing ocular GVHD development.

Detailed Description

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This is a prospective single arm interventional study.

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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Leukemia (Both ALL and AML) MDS-EB-1

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Single arm

Ikervis (cyclosporine 0.1%), emulsion, one drop into both eyes, once at night.

Group Type OTHER

Cyclosporine Ophthalmic

Intervention Type DRUG

Prospective interventional study (single arm)

Interventions

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Cyclosporine Ophthalmic

Prospective interventional study (single arm)

Intervention Type DRUG

Other Intervention Names

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Ikervis

Eligibility Criteria

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Inclusion Criteria

* Age 13 and above
* Able to give informed consent

Exclusion Criteria

* Presence of concurrent disease
* Unable to complete the follow up
Minimum Eligible Age

13 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Singapore Eye Research Institute

OTHER

Sponsor Role lead

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Lim

Role: PRINCIPAL_INVESTIGATOR

Senior Consultant

Locations

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Singapore Eye Research Institute

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Li Lim

Role: CONTACT

Phone: 63224500

Email: [email protected]

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.

Reference Type DERIVED
PMID: 36856978 (View on PubMed)

Other Identifiers

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R1641/38/2019

Identifier Type: -

Identifier Source: org_study_id