| CTRI Number |
CTRI/2025/04/085354 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Role of insulin eye drops in diseased corneas with reduced sensation |
|
Scientific Title of Study
|
Role of Topical Insulin Therapy in Stage 2 Neurotrophic Keratopathy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pallavi Joshi |
| Designation |
Senior Consultant |
| Affiliation |
Sankara Eye Hospital, Bengaluru, Karnataka |
| Address |
Dept. of Cornea & Refractive Surgery, Sankara Eye Hospital
Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru
Bangalore
KARNATAKA
560037
India |
| Phone |
8147280162 |
| Fax |
|
| Email |
drpallavijoshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi Joshi |
| Designation |
Senior Consultant |
| Affiliation |
Sankara Eye Hospital, Bengaluru, Karnataka |
| Address |
Dept. of Cornea & Refractive Surgery, Sankara Eye Hospital
Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru
Bangalore
KARNATAKA
560037
India |
| Phone |
8147280162 |
| Fax |
|
| Email |
drpallavijoshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Joshi |
| Designation |
Senior Consultant |
| Affiliation |
Sankara Eye Hospital, Bengaluru, Karnataka |
| Address |
Dept. of Cornea & Refractive Surgery, Sankara Eye Hospital
Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru
Bangalore
KARNATAKA
560037
India |
| Phone |
8147280162 |
| Fax |
|
| Email |
drpallavijoshi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru, Karnataka 560037 |
| 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 Nitish Kumar |
Sankara Eye Hospital |
Room No. 28, Ground Floor, Dept. of Cornea & Refractive Surgery
Varthur Main Rd Vaikuntam Layout Lakshminarayana Pura Kundalahalli Munnekollal Bengaluru
Bangalore
KARNATAKA |
9871328362
nitishkumar007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sankara Eye Hospital Bengaluru, Karnataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H168||Other keratitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Patients being treated with only Poly Ethylene Glycol eyedrops eyedrops |
Patient with neurotrophic keratopathy will be started on Poly Ethylene Glycol eyedrops They will be followed up after 1 week 1 month 2 month and 3 months respectively. |
| Intervention |
Patients being treated with only topical insulin eyedrops |
Patient with neurotrophic keratopathy will be started on Topical Insulin eyedrops
They will be followed up after 1 week 1 month 2 month and 3 months respectively.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Severe Dry Eye Disease
Viral keratitis
Chemical or mechanical trauma
Chronic use of preserved Topical eyedrops
Post- Ocular surgery or Neurosurgery
Post irradiation
Diabetes mellitus/ Keratopathy
Recurrent Epithelial Erosions
Neurological conditions like Vascular/ Space occupying lesions |
|
| ExclusionCriteria |
| Details |
Patients not willing for insulin therapy
Pregnant & Nursing Mothers
Active non-herpetic keratitis
Post Keratoplasty Neurotrophic keratopathy
One eyed patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Complete re epithelialization of the Persistent Epithelial Defect |
Patient will be followed up after 1 week 1 month 2 months and 3 months respectively
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Best-corrected visual acuity
2 Days until complete re-epithelialization
3 Any change in corneal sensation
4 Changes in Dry Eye Profile
5 Serial Slit Lamp Photo Evaluation
6 Changes in Epithelial Profile Impression Cytology using cellulose acetate filter paper
|
Patient will be followed up after 1 week 1 month 2 months and 3 months respectively
|
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
28/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Suspended |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patient with neurotrophic keratopathy (NK) will undergo routine visual acuity testing Uncorrected and best corrected visual acuity. Slit lamp bio-microscopy examination will be done and classified into the stage of NK based on the clinical findings. Corneal Sensations will be done by Cochet Bonnet esthesiometer. Slit Lamp photography & dry eye imaging (keratograph) will be done subsequently. Impression cytology sample will be taken before starting any topical therapy. Topical therapy i.e. Topical Insulin ( Group A) & Poly Ethylene Glycol (Group B) eyedrops will be started. Patient will be followed up after 1 week 1 month 2 months & 3 months respectively. If the patients on topical insulin therapy does not show any improvement at one week follow up they will be shifted to conventional therapy depending on the clinical findings. The washout period of insulin eyedrops in 1-2 days & has no local or systemic side effects as shown in the literature. |