Back to resultsThe Effects of Ripasudil in Patients With FED Undergoing Femtosecond Laser Assisted Cataract Surgery
Primary Purpose
Fuchs' Endothelial Dystrophy, Cataract
Status
Recruiting
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
Ripasudil
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Fuchs' Endothelial Dystrophy focused on measuring Ripasudil
Eligibility Criteria
Inclusion Criteria: Patients with FED who will be listed for cataract surgery as part of standard clinical practice (A cataract will be defined as clouding of the lens that interferes with normal vision). Only patients older than 50 years will be included, as cataracts develops with increasing age. No gender criteria are applied. Ability to provide informed consent, and are willing and able to sign a written Informed Consent Form prior to any study-specific procedures. Patients must be willing and able to return for scheduled follow-up examinations for up to 12 months after the surgery. Exclusion Criteria: Patients who are unable to give consent. An only-functioning eye in a patient who has lost visual potential in the contralateral eye. Diagnosis of clinically relevant eye diseases that may interfere with the aim of the study. History of ripasudil use, as well as other systemic disease such as cardiovascular or renal disease. Patients who have previous allergic reactions to the contents present in Glanatec Ophthalmic solution 0.4%
Sites / Locations
- Singapore National Eye CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Placebo
Arm Description
Participants in this group will be asked to instill Glanatec Ophthalmic Solution (containing Ripasadil 0.4%) 4 times a day for 3 months following cataract removal surgery.
Participants in this group will be asked to instill saline solution 4 times a day for 3 months following cataract removal surgery.
Outcomes
Primary Outcome Measures
Average endothelial cell density (ECD) is higher in participants in treatment group than participants in placebo.
The ECD at 15 different locations of the cornea is measured with a widefield specular microscope.
This assessment will be done pre-surgery, 1 month, 3 months and 6 months post-surgery.
Secondary Outcome Measures
To monitor for conjunctival hyperemia in participants in treatment group.
The Cornea and Contact Lens Research Unit (CCLRU) grading scale will be used as an objective assessment guideline for grading conjunctival hyperaemia.
The investigators will grade the conjunctival hyperemia 1 month, 3 months and 6 months post surgery.
To monitor for gastrointestinal effects in participants in treatment group.
Investigators will ask participants if they experience gastrointestinal upset, abdominal pain or constipation during 1 month, 3 months and 6 months post surgery.
Full Information
NCT ID
NCT06048380
First Posted
June 26, 2023
Last Updated
September 15, 2023
Sponsor
Singapore Eye Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT06048380
Brief Title
The Effects of Ripasudil in Patients With FED Undergoing Femtosecond Laser Assisted Cataract Surgery
Official Title
The Effects of Ripasudil in Patients With Fuchs Endothelial Corneal Dystrophy Undergoing Femtosecond Laser Assisted Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Singapore Eye Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of this research is to investigate the effects of ripasudil administered as an ophthalmic solution in patients with FED after femtosecond laser assisted cataract surgery. The secondary aim is to identity the characteristics of patients who will benefit the most with the use of ripasudil based on the test results obtained from this study.
Detailed Description
Patients with Fuch's Corneal Endothelial Dystrophy and undergoing femtosecond laser-assisted cataract surgery will be recruited for this study. They will be randomly assigned into treatment or placebo group.
The investigators hypothesize that the ROCK inhibitor ripasudil 0.4% helps maintain corneal endothelial functional integrity and reduce cell loss after cataract surgery in patients with FED.
To test the hypothesis, the investigators plan to conduct a randomized clinical trial which aims to:
Evaluate the clinical outcomes of FED eyes following FLACS with and without ripasudil 0.4%
To identity which FED patients will most likely benefit from the use of ripasudil 0.4% based on pre-operative parameters
To monitor for any adverse effects in patients assigned to ripasudil 0.4%
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs' Endothelial Dystrophy, Cataract
Keywords
Ripasudil
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Participants in this group will be asked to instill Glanatec Ophthalmic Solution (containing Ripasadil 0.4%) 4 times a day for 3 months following cataract removal surgery.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in this group will be asked to instill saline solution 4 times a day for 3 months following cataract removal surgery.
Intervention Type
Drug
Intervention Name(s)
Ripasudil
Other Intervention Name(s)
Glanatec
Intervention Description
Glanatec Ophthalmic Solution 0.4% W/V with ripasudil hydrochloride hydrate as active ingredient is currently being used by patients with ocular hypertension or open-angle glaucoma.
Inhibition of Rho kinase to facilitate aqueous outflow from the conventional outflow pathway via the trabecular meshwork and Schlemm's canal has been suggested as the IOP-lowering mechanism of action by ripasudil.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Saline eye drops
Primary Outcome Measure Information:
Title
Average endothelial cell density (ECD) is higher in participants in treatment group than participants in placebo.
Description
The ECD at 15 different locations of the cornea is measured with a widefield specular microscope.
This assessment will be done pre-surgery, 1 month, 3 months and 6 months post-surgery.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
To monitor for conjunctival hyperemia in participants in treatment group.
Description
The Cornea and Contact Lens Research Unit (CCLRU) grading scale will be used as an objective assessment guideline for grading conjunctival hyperaemia.
The investigators will grade the conjunctival hyperemia 1 month, 3 months and 6 months post surgery.
Time Frame
6 months
Title
To monitor for gastrointestinal effects in participants in treatment group.
Description
Investigators will ask participants if they experience gastrointestinal upset, abdominal pain or constipation during 1 month, 3 months and 6 months post surgery.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with FED who will be listed for cataract surgery as part of standard clinical practice (A cataract will be defined as clouding of the lens that interferes with normal vision).
Only patients older than 50 years will be included, as cataracts develops with increasing age. No gender criteria are applied.
Ability to provide informed consent, and are willing and able to sign a written Informed Consent Form prior to any study-specific procedures.
Patients must be willing and able to return for scheduled follow-up examinations for up to 12 months after the surgery.
Exclusion Criteria:
Patients who are unable to give consent.
An only-functioning eye in a patient who has lost visual potential in the contralateral eye.
Diagnosis of clinically relevant eye diseases that may interfere with the aim of the study.
History of ripasudil use, as well as other systemic disease such as cardiovascular or renal disease.
Patients who have previous allergic reactions to the contents present in Glanatec Ophthalmic solution 0.4%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcus Ang
Phone
+65 62277255
Email
Marcus.Ang@Singhealth.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Ang
Organizational Affiliation
Singapore Eye Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore National Eye Centre
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcus Ang
Phone
+65 62277255
Email
Marcus.Ang@Singhealth.com.sg
First Name & Middle Initial & Last Name & Degree
Marcus Ang
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Ripasudil in Patients With FED Undergoing Femtosecond Laser Assisted Cataract Surgery
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