Leukemia (Both ALL and AML)Phase 4IkervisNCT04636918
Ikervis for DED Due to GVHD Post Allo-HSCT
A Phase 4 study testing Cyclosporine Ophthalmic in people with Leukemia (Both ALL and AML) and MDS-EB-1, run by Singapore Eye Research Institute at 1 site in Singapore.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 13 to 95 years
- Conditions the study is for
- Leukemia (Both ALL and AML), MDS-EB-1
- What is being tested?
- Cyclosporine Ophthalmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 28 Nov 2019to 30 Dec 2022
- Phase
- Phase 4
- 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 13 to 95 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 13 and above
- Able to give informed consent
Who cannot join
- Presence of concurrent disease
- Unable to complete the follow up
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore Eye Research Institute
Singapore
Li Lim, 63224500, lim.li@singhealth.com.sg
About this study
Official title: Ikervis for Prophylaxis of Dry Eye Disease Due to Graft vs Host Disease Post Allogeneic Haemtopoietic Stem Cell Transplant
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.
Read the detailed description
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
- Leukemia (Both ALL and AML), MDS-EB-1
- Being tested
- Cyclosporine Ophthalmic
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine OphthalmicDrug
Also called Ikervis
Prospective interventional study (single arm)
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Ikervis (cyclosporine 0.1%), emulsion, one drop into both eyes, once at night. Receives: Drug: Cyclosporine Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess change in basline visual acuity using LogMAR chart with prophylactic Ikervis after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
Visual acuity will be assessed using LogMAR chart at baseline screening and 3, 6, and 12 months post-HSCT after prophylactic Ikervis.
Measured: Baseline, 3 months, 6 months and 1 year post-HSCT follow up
To assess change in baseline intraocular pressure using non-contact tonometry with 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
Intraocular pressure (mmHg) will be assessed using non-contact tonometry at baseline screening and 3, 6, and 12 months post-HSCT after prophylactic Ikervis.
Measured: Baseline, 3 months, 6 months and 1 year post-HSCT follow up
To assess change in baseline anterior ocular health using slit lamp examination with 12 months post Haematopoietic Stem Cell Transplant.
Slit lamp examination will be performed at baseline screening and 12 months post-HSCT after prophylactic Ikervis. Clinical findings such as macroerosions or chemosis on cornea, or cataract will be recorded.
Measured: Baseline screening and 1 year post-HSCT follow up
To assess change in baseline posterior ocular health using fundus examination with 12 months post Haematopoietic Stem Cell Transplant.
Fundus examination will be performed at baseline screening and 12 months post-HSCT after prophylactic Ikervis. Clinical findings such as cup disc ratio will be graded from 0.0 to 1.0 (greater value means larger cup), hemorrhage, edema of the retina/macular will be recorded.
Measured: Baseline screening and 1 year post-HSCT follow up
To assess change of baseline dry eye symptoms with prophylactic Ikervis after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
Dry eye symptoms will be assessed using SPEED questionnaire (in score 0-28). A higher score means worse dry eye symptom. The change of dry eye symptoms will be assess from baseline before prophylactic Ikervis, 3 to 5 weeks from baseline (Pre-HSCT), and 3, 6, and 12 months post-HSCT after prophylactic Ikervis.
Measured: Baseline, 3 to 5 weeks from baseline (Pre-HSCT), 3 months, 6 months and 1 year post-HSCT follow up
To assess change of baseline non-invasive tear break up time with prophylactic Ikervis after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
Non-invasive tear break up time (in seconds) will be assessed using Oculus Keratography K5M. The change of NITBUT will be assessed from baseline before prophylactic Ikervis, pre-HSCT, and 3, 6, and 12 months post-HSCT after prophylactic Ikervis.
Measured: Baseline, 3 to 5 weeks from baseline (Pre-HSCT), 3 months, 6 months and 1 year post-HSCT follow up
To assess change of baseline conjunctival redness with prophylactic Ikervis after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
Conjunctival Redness (in grading 0-4) will be assessed using Oculus Keratography K5M. A higher grading means conjunctiva is more red. The change of conjunctival redness will be assessed from baseline before prophylactic Ikervis, pre-HSCT, and 3, 6, and 12 months post-HSCT after prophylactic Ikervis.
Measured: Baseline, 3 to 5 weeks from baseline (Pre-HSCT), 3 months, 6 months and 1 year post-HSCT follow up
To assess change of baseline tear lipid thickness with prophylactic Ikervis 12 months post Haematopoietic Stem Cell Transplant.
Tear lipid thickness will be measured using LipiView. The change of tear lipid thickness will be only be assessed from baseline before prophylactic Ikervis and 12 months post-HSCT after prophylactic Ikervis.
Measured: Baseline and 1 year post-HSCT follow up
To assess change of baseline Meibomian gland status with prophylactic Ikervis 12 months post Haematopoietic Stem Cell Transplant.
Meibomian gland (in grade 0-3) will be assessed using Infra-red Meibography. We will grade the Meibomian gland disease as: 0, no loss of meibomian glands; 1, lost area was less than one third of the total area of meibomian glands; 2, lost area was between one third and two thirds of the total area of meibomian glands; 3, lost area was over two thirds of the total area of meibomian glands. The change of meibomian gland will be assessed from baseline before prophylactic Ikervis pre-HSCT and 12 months post-HSCT after prophylactic Ikervis.
Measured: Baseline and 1 year post-HSCT follow up
To assess change of baseline tear cytokines with prophylactic Ikervis after 3 to 5 weeks after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
Tear cytokine will be analysed with tears extracted from Schirmers test. The change of tear cytokines will be assess from baseline before prophylactic Ikervis, 3 to 5 weeks from baseline (Pre-HSCT), and 3, 6, and 12 months post-HSCT after prophylactic Ikervis.
Measured: Baseline, 3 to 5 weeks from baseline (Pre-HSCT), 3 months, 6 months and 1 year post-HSCT follow up
To assess change of conjunctival impression cytology 3 to 5 weeks after prophylactic Ikervis with 12 months post Haematopoietic Stem Cell Transplant.
Conjunctival impression cytology will be performed using EyePrim. The change of conjunctival impression cytology only will be assessed 3 to 5 weeks from baseline (Pre-HSCT) and 12 months post-HSCT after prophylactic Ikervis.
Measured: 3 to 5 weeks from baseline (Pre-HSCT) and 1 year post-HSCT follow up
To assess change of baseline corneal fluorescein staining score with prophylactic Ikervis after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
Corneal fluorescein staining (in grade 0-4) will be imaged by Oculus Keratograph K5M. A greater number indicating more intense or greater area of staining. The change of corneal fluorescein staining will be assess from baseline before prophylactic Ikervis, 3 to 5 weeks from baseline (Pre-HSCT), and 3, 6, and 12 months post-HSCT after prophylactic Ikervis.
Measured: Baseline, 3 to 5 weeks from baseline (Pre-HSCT), 3 months, 6 months and 1 year post-HSCT follow up
To assess change of baseline Meibomian gland expressibility with prophylactic Ikervis after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
Meibomian gland expressibility will be assessed using Meibomian gland evaluator. Texture of expressed secretion will be graded as liquid or viscous. The number of expressible glands will be recorded. The change of meibomian gland expressibility will be assess from baseline before prophylactic Ikervis, 3 to 5 weeks from baseline (Pre-HSCT), and 3, 6, and 12 months post-HSCT after prophylactic Ikervis.
Measured: Baseline, 3 to 5 weeks from baseline (Pre-HSCT), 3 months, 6 months and 1 year post-HSCT follow up
To assess Quality of Life Questionnaire at 12 months post Haematopoietic Stem Cell Transplant.
Quality of Life (in score 0, 1, 2, 3, 8) will be assessed using Impact of Vision Impairment Profile questionnaire at the end of the prophylactic Ikervis, 12 months post-HSCT. The score in 0 means a lot of the time, 1 means a fair amount of the time, 2 means a little of the time, 3 means not at all, 8 means do not do this for other reasons.
Measured: 1 year post-HSCT follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start28 Nov 2019
- Primary completion22 Aug 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leukemia (Both ALL and AML)Studies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore Eye Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lim Li, Singapore Eye Research Institute
- Investigators
- Li Lim, Principal investigator, Senior Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636918
- Sponsor's protocol ID
- R1641/38/2019
- Acronym
- Ikervis
- Status last verified
- Nov 2020
- First submitted
- 9 Mar 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36856978
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ikervis for Prophylaxis of Dry Eye Disease Due to Graft vs Host Disease Post Allogeneic Haemtopoietic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT04636918
- Acronym / sponsor ID
- Ikervis / R1641/38/2019
- Conditions
- Leukemia (Both ALL and AML), MDS-EB-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Singapore Eye Research InstituteUniversity, hospital or other
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 22 Aug 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 19 Nov 2020 (actual)
- 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.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Drug: Cyclosporine OphthalmicIkervis (cyclosporine 0.1%), emulsion, one drop into both eyes, once at night. |
Who may qualify
- Ages
- 13 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age 13 and above
- Able to give informed consent
Key exclusion criteria (2 listed)
- Presence of concurrent disease
- Unable to complete the follow up
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 |
|---|---|---|
| Cyclosporine OphthalmicAlso: IkervisProspective interventional study (single arm) | Drug | Single arm |
Primary outcome
To assess change in basline visual acuity using LogMAR chart with prophylactic Ikervis after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
Time frame: Baseline, 3 months, 6 months and 1 year post-HSCT follow up
Visual acuity will be assessed using LogMAR chart at baseline screening and 3, 6, and 12 months post-HSCT after prophylactic Ikervis.
To assess change in baseline intraocular pressure using non-contact tonometry with 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
Time frame: Baseline, 3 months, 6 months and 1 year post-HSCT follow up
Intraocular pressure (mmHg) will be assessed using non-contact tonometry at baseline screening and 3, 6, and 12 months post-HSCT after prophylactic Ikervis.
To assess change in baseline anterior ocular health using slit lamp examination with 12 months post Haematopoietic Stem Cell Transplant.
Time frame: Baseline screening and 1 year post-HSCT follow up
Slit lamp examination will be performed at baseline screening and 12 months post-HSCT after prophylactic Ikervis. Clinical findings such as macroerosions or chemosis on cornea, or cataract will be recorded.
To assess change in baseline posterior ocular health using fundus examination with 12 months post Haematopoietic Stem Cell Transplant.
Time frame: Baseline screening and 1 year post-HSCT follow up
Fundus examination will be performed at baseline screening and 12 months post-HSCT after prophylactic Ikervis. Clinical findings such as cup disc ratio will be graded from 0.0 to 1.0 (greater value means larger cup), hemorrhage, edema of the retina/macular will be recorded.
To assess change of baseline dry eye symptoms with prophylactic Ikervis after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
Time frame: Baseline, 3 to 5 weeks from baseline (Pre-HSCT), 3 months, 6 months and 1 year post-HSCT follow up
Dry eye symptoms will be assessed using SPEED questionnaire (in score 0-28). A higher score means worse dry eye symptom. The change of dry eye symptoms will be assess from baseline before prophylactic Ikervis, 3 to 5 weeks from baseline (Pre-HSCT), and 3, 6, and 12 months post-HSCT after prophylactic Ikervis.
To assess change of baseline non-invasive tear break up time with prophylactic Ikervis after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
Time frame: Baseline, 3 to 5 weeks from baseline (Pre-HSCT), 3 months, 6 months and 1 year post-HSCT follow up
Non-invasive tear break up time (in seconds) will be assessed using Oculus Keratography K5M. The change of NITBUT will be assessed from baseline before prophylactic Ikervis, pre-HSCT, and 3, 6, and 12 months post-HSCT after prophylactic Ikervis.
To assess change of baseline conjunctival redness with prophylactic Ikervis after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
Time frame: Baseline, 3 to 5 weeks from baseline (Pre-HSCT), 3 months, 6 months and 1 year post-HSCT follow up
Conjunctival Redness (in grading 0-4) will be assessed using Oculus Keratography K5M. A higher grading means conjunctiva is more red. The change of conjunctival redness will be assessed from baseline before prophylactic Ikervis, pre-HSCT, and 3, 6, and 12 months post-HSCT after prophylactic Ikervis.
To assess change of baseline tear lipid thickness with prophylactic Ikervis 12 months post Haematopoietic Stem Cell Transplant.
Time frame: Baseline and 1 year post-HSCT follow up
Tear lipid thickness will be measured using LipiView. The change of tear lipid thickness will be only be assessed from baseline before prophylactic Ikervis and 12 months post-HSCT after prophylactic Ikervis.
To assess change of baseline Meibomian gland status with prophylactic Ikervis 12 months post Haematopoietic Stem Cell Transplant.
Time frame: Baseline and 1 year post-HSCT follow up
Meibomian gland (in grade 0-3) will be assessed using Infra-red Meibography. We will grade the Meibomian gland disease as: 0, no loss of meibomian glands; 1, lost area was less than one third of the total area of meibomian glands; 2, lost area was between one third and two thirds of the total area of meibomian glands; 3, lost area was over two thirds of the total area of meibomian glands. The change of meibomian gland will be assessed from baseline before prophylactic Ikervis pre-HSCT and 12 months post-HSCT after prophylactic Ikervis.
To assess change of baseline tear cytokines with prophylactic Ikervis after 3 to 5 weeks after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
Time frame: Baseline, 3 to 5 weeks from baseline (Pre-HSCT), 3 months, 6 months and 1 year post-HSCT follow up
Tear cytokine will be analysed with tears extracted from Schirmers test. The change of tear cytokines will be assess from baseline before prophylactic Ikervis, 3 to 5 weeks from baseline (Pre-HSCT), and 3, 6, and 12 months post-HSCT after prophylactic Ikervis.
To assess change of conjunctival impression cytology 3 to 5 weeks after prophylactic Ikervis with 12 months post Haematopoietic Stem Cell Transplant.
Time frame: 3 to 5 weeks from baseline (Pre-HSCT) and 1 year post-HSCT follow up
Conjunctival impression cytology will be performed using EyePrim. The change of conjunctival impression cytology only will be assessed 3 to 5 weeks from baseline (Pre-HSCT) and 12 months post-HSCT after prophylactic Ikervis.
To assess change of baseline corneal fluorescein staining score with prophylactic Ikervis after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
Time frame: Baseline, 3 to 5 weeks from baseline (Pre-HSCT), 3 months, 6 months and 1 year post-HSCT follow up
Corneal fluorescein staining (in grade 0-4) will be imaged by Oculus Keratograph K5M. A greater number indicating more intense or greater area of staining. The change of corneal fluorescein staining will be assess from baseline before prophylactic Ikervis, 3 to 5 weeks from baseline (Pre-HSCT), and 3, 6, and 12 months post-HSCT after prophylactic Ikervis.
To assess change of baseline Meibomian gland expressibility with prophylactic Ikervis after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant.
Time frame: Baseline, 3 to 5 weeks from baseline (Pre-HSCT), 3 months, 6 months and 1 year post-HSCT follow up
Meibomian gland expressibility will be assessed using Meibomian gland evaluator. Texture of expressed secretion will be graded as liquid or viscous. The number of expressible glands will be recorded. The change of meibomian gland expressibility will be assess from baseline before prophylactic Ikervis, 3 to 5 weeks from baseline (Pre-HSCT), and 3, 6, and 12 months post-HSCT after prophylactic Ikervis.
To assess Quality of Life Questionnaire at 12 months post Haematopoietic Stem Cell Transplant.
Time frame: 1 year post-HSCT follow up
Quality of Life (in score 0, 1, 2, 3, 8) will be assessed using Impact of Vision Impairment Profile questionnaire at the end of the prophylactic Ikervis, 12 months post-HSCT. The score in 0 means a lot of the time, 1 means a fair amount of the time, 2 means a little of the time, 3 means not at all, 8 means do not do this for other reasons.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Derived from this study: PubMed 36856978Tong 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.
- Individual participant dataSharing planned: No
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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.
Li Lim principal investigator
Senior Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyclosporine Ophthalmic in people with Leukemia (Both ALL and AML) and MDS-EB-1, run by Singapore Eye Research Institute at 1 site in Singapore.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Lim (63224500, lim.li@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess change in basline visual acuity using LogMAR chart with prophylactic Ikervis after 3 to 5 weeks before Haematopoietic Stem Cell Transplant and 3 months, 6 months and 12 months post Haematopoietic Stem Cell Transplant. (time frame: Baseline, 3 months, 6 months and 1 year post-HSCT follow up). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04636918, which also lists 1 linked publication.
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 19 Nov 2020.