| CTRI Number |
CTRI/2024/06/069019 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The effects of Topical Insulin on Dry eye disease in Type 2 Diabetic patients |
|
Scientific Title of Study
|
The effects of Topical Insulin on Dry eye disease in Type 2 Diabetic patients -A Randomised Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Professor Adeeb Alam khan |
| Designation |
Professor |
| Affiliation |
Institute of Ophthalmology Jawaharlal Nehru Medical College and Hospital |
| Address |
Room Number 6
Institute of Ophthalmology
Jawaharlal Nehru Medical College and Hospital
Aligarh Muslim University
Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9837252564 |
| Fax |
|
| Email |
dradeebkhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ritika Goel |
| Designation |
Ophthalmology Resident |
| Affiliation |
Institute of Ophthalmology Jawaharlal Nehru Medical College and Hospital |
| Address |
Room Number 9 Institute of Ophthalmology Jawaharlal Nehru Medical College and Hospital Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9119033990 |
| Fax |
|
| Email |
9114ritika@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Professor Adeeb Alam khan |
| Designation |
Professor Ophthalmology |
| Affiliation |
Institute of Ophthalmology Jawaharlal Nehru Medical College and Hospital |
| Address |
Room number 6
Institute of Ophthalmology
Jawaharlal Nehru Medical College and Hospital
Aligarh Muslim University
Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9837252564 |
| Fax |
|
| Email |
dradeebkhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Ophthalmology
Jawaharlal Nehru Medical College and Hospital
Aligarh Muslim University Aligarh 202002
Uttar Pradesh
India |
|
|
Primary Sponsor
|
| Name |
Dr Ritika Goel |
| Address |
Room Number 9 Institute of Ophthalmology Jawaharlal Nehru Medical College and Hospital Aligarh Muslim University
Aligarh 202002
Uttar Pradesh
India |
| Type of Sponsor |
Other [(self) ] |
|
|
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 Adeeb Alam Khan |
Jawaharlal Nehru Medical College and Hospital Aligarh Muslim University |
Eye OPD 21 and Cornea and Dry Eye Clinic
Institute of Ophthalmology
Aligarh
UTTAR PRADESH |
9837252564
dradeebkhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Jawaharlal Nehru Medical College and Hospital Faculty of Medicine Aligrah Muslim University Aligarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Eye drop polyethylene glycol 400 propylene glycol |
Eye drop polyethylene glycol 400 0.4% and propylene glycol 0.3% one drop instilled in both eyes four times a day for 8 weeks |
| Intervention |
Topical Insulin eye drops |
Insulin eye drops in concentration of 25U/ml 1 drop instilled in both eyes 4 times a day for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 Diabetes mellitus
Age above 30years
Baseline OSDI score more than 14 |
|
| ExclusionCriteria |
| Details |
Sjogren syndrome
Already Instilling any eye drops
Use of contact lens
History of ocular Trauma/ chemical injury / ocular surgery
On systemic insulin
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare OSDI score and dry eye parameters before and after use of topical insulin |
Topical insulin given for 8 weeks four times a day and the parameters will be assessed at baseline, 4 weeks and at 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare OSDI score & dry eye parameters in topical insulin & artificial tear substitute group |
Artificial tears given for 8 weeks four times a day & parameters will be assessed at baseline, 4 weeks at 8 weeks. The results will be compared with topical insulin |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [9114ritika@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 01-07-2035?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Diabetes mellitus is recognised as one of the important risk factors for Dry Eye Disease.Diabetics have shown to have lower Schirmer and Tear break up time measurements. Insulin receptor and insulin-like growth factor (IGF)-1 receptor are found in Plasma membrane and cytoplasm of corneal and conjunctival epithelial cells in a study conducted by Rocha et al.Topical Insulin plays a role in treatment of persistent epithelial defects and it has been found to decrease resolution time of neurotrophic ulcers. In Malaysia in January 2020 a Randomised trial by Azmi et al. to assess the short-term effects of topical insulin on the signs and symptoms of DED in DM patients. We will be doing a randomised control trial to study the effects of insulin eye drops in Type 2 diabetic patients with dry eye disease. Control group will be using polyethylene glycol eye drops .The drugs will be used for 8 weeks four times a day. OSDI score, tear break up time and schirmers 1 and 2 will be assessed at baseline and after the end of therapy . The Results will be analysed and compared.
|