| CTRI Number |
CTRI/2022/09/045191 [Registered on: 02/09/2022] Trial Registered Prospectively |
| Last Modified On: |
01/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Effect of pressure reducing effect of Ripasudil eye drops in patients with high pressure within the eye |
|
Scientific Title of Study
|
Evaluation of intraocular pressure lowering effect of 0.4% Ripasudil eye drops in patients with primary open angle glaucoma and ocular hypertension |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amritha Madhu |
| Designation |
Primary DNB resident (ophthalmology) |
| Affiliation |
Sankara eye hospital Shimoga |
| Address |
Sankara eye hospital, Thirthahalli Road, Harakere, Shimoga
Shimoga
KARNATAKA
577202
India |
| Phone |
9900684631 |
| Fax |
|
| Email |
amrithaamritham56@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamala S |
| Designation |
Senior consultant glaucoma |
| Affiliation |
Sankara eye hospital, Shimoga |
| Address |
Sankara eye hospital, Thirthahalli Road, Harakere, Shimoga
Sankara eye hospital, Thirthahalli Road, Harakere, Shimoga
Shimoga
KARNATAKA
577202
India |
| Phone |
9480362192 |
| Fax |
|
| Email |
kamala13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amritha Madhu |
| Designation |
Primary DNB resident (ophthalmology) |
| Affiliation |
Sankara eye hospital, Shimoga |
| Address |
Sankara eye hospital, Thirthahalli Road, Harakere, Shimoga
Sankara eye hospital, Thirthahalli Road, Harakere, Shimoga
Shimoga
KARNATAKA
577202
India |
| Phone |
9900684631 |
| Fax |
|
| Email |
amrithaamritham56@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara eye hospital, Thirthahalli road, Harakere, Shimoga, Karnataka 577202 |
|
|
Primary Sponsor
|
| Name |
Sankara eye hospital |
| Address |
Sankara eye hospital
Thirthahalli Road
Harakere
Shimoga |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amritha Madhu |
Sankara eye hospital, Shimoga |
Sankara eye hospital, Thirthahalli road, Harakere, Shimoga
Shimoga
KARNATAKA |
9900684631
amrithaamritham56@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Sankara Eye Hospital, Shimoga |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Patients with newly diagnosed primary open angle glaucoma and ocular hypertension, with central corneal thickness corrected IOP more than or equal to 22mmHg will be given Ripasudil eye drops |
0.4% Ripasudil eye drops will be instilled to the eye, one drop daily, BD for lifelong and intraocular pressure is measured at baseline, 4 weeks, 12 weeks and 24 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Central Corneal Thickness corrected intraocular pressure more than or equal to 22mmHg which includes primary open angle glaucoma and ocular hypertension |
|
| ExclusionCriteria |
| Details |
Patients with history of ocular trauma
Patients with history of intraocular surgery
Secondary glaucomas like angle closure glaucoma, neovascular glaucoma, pseudo-exfoliative glaucoma, pigmentary glaucoma
Patients with pre-existing corneal diseases
Pre-existing dry eye
Patients with allergic conjunctivitis
Pregnant and lactating women
Patients who are not willing for follow up |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the intraocular pressure lowering effect of 0.4% Ripasudil eye drops in patients with primary open angle glaucoma and ocular hypertension |
Intraocular pressure is measured at baseline, 4 weeks, 12 weeks and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the IOP lowering effect of Ripasudil as a monotherapy or as an additive agent |
By comparing IOP at presentation (baseline) and at 1st month, 3rd months, 6th months |
| To assess the requirement of additional ocular hypotensive drug in those patients on Ripasudil therapy |
By comparing IOP at presentation (baseline) and at 1st month, 3rd months, 6th months |
| To assess the incidence of side effects with Ripasudil |
By assessing the side effects at 1st month, 3rd month and 6th month |
| To assess the requirement of additional lubricants to continue Ripasudil |
By assessing the side effects at 1st month, 3rd month and 6th month |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/09/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Glaucoma is a group of progressive optic neuropathy characterised by typical damage to the optic nerve head (cupping) and associated visual dysfunction. Glaucoma is the main cause of irreversible vision loss in adults worldwide. Glaucomatous damage to the optic nerve appears to be the final common pathway to a diverse assortment of etiologic factors and clinical subtypes. An increase of intraocular pressure (IOP) is the primary risk factor for the development and progression of glaucoma. Thus, the most effective treatment for glaucoma is the lowering of raised IOP. Topical antiglaucoma eye drops are used as the primary treatment for the reduction of IOP. Ripasudil hydrochloride hydrate is a rho-associated coiled - coil forming kinase (ROCK) inhibitor, which reduces IOP by enhancing conventional aqueous humor outflow via changes in the morphology of trabecular meshwork cells, inhibition of extracellular matrix production, and increased juxta - Schlemm canal permeability. Ripasudil eyedrops at 0.4% concentration can significantly lower IOP in patients with primary open angle glaucoma (POAG) and ocular hypertension (OHT). ROCK inhibitors can increase aqueous humor outflow and decrease IOP by targeting the cytoskeleton of the trabecular meshwork and Schlemm’s canal cells. |