| CTRI Number |
CTRI/2021/11/038214 [Registered on: 23/11/2021] Trial Registered Prospectively |
| Last Modified On: |
22/11/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of Insulin Eye Drops in Diabetic Dry Eye Patients |
|
Scientific Title of Study
|
Efficacy and Safety of Topical Insulin on Ocular Surface Stability, Tear Film and Symptomatology in Patients with Dry Eye Disease and Diabetes Mellitus: A Randomized Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jeewan Singh Titiyal |
| Designation |
Professor |
| Affiliation |
Dr R P Centre for Ophthalmic Sciences, All Institute of Medical Sciences, Delhi |
| Address |
Room 491
DR R P Centre, AIIMS,
Ansari Nagar
New Delhi, India
Ansari Nagar
New Delhi, India
South
DELHI
110029
India |
| Phone |
01126593146 |
| Fax |
|
| Email |
titiyal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sridevi Nair |
| Designation |
Research Officer |
| Affiliation |
Dr R P Centre for Ophthalmic Sciences, All Institute of Medical Sciences, Delhi |
| Address |
Room 491
DR R P Centre, AIIMS,
Ansari Nagar
New Delhi, India
Ansari Nagar
New Delhi, India
South
DELHI
110029
India |
| Phone |
01126593146 |
| Fax |
|
| Email |
srideviaiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sridevi Nair |
| Designation |
Research Officer |
| Affiliation |
Dr R P Centre for Ophthalmic Sciences, All Institute of Medical Sciences, Delhi |
| Address |
Room 491
DR R P Centre, AIIMS,
Ansari Nagar
New Delhi, India
Ansari Nagar
New Delhi, India
South
DELHI
110029
India |
| Phone |
01126593146 |
| Fax |
|
| Email |
srideviaiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr R P Centre for Ophthalmic Siecnes |
|
|
Primary Sponsor
|
| Name |
Dr R P Centre for Ophthalmic Sciences |
| Address |
Ansari Nagar, AIIMS |
| Type of Sponsor |
Government medical college |
|
|
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 Sridevi Nair |
Dr R P Centre for Ophthalmic Sciences |
Ansari Nagar
New Delhi, India
South
DELHI |
01126593146
srideviaiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Artificial tears |
Artificial tears with polyethylene glycol and polypropylene glycol base |
| Intervention |
Topical Insulin eye drops (1 IU/mL) |
Topical Insulin eye drops (1 IU/mL) prepared in artificial tears with polyethylene glycol and polypropylene glycol base. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Type II Diabetic patients, >18 years of age, diagnosed with mild-moderate dry eye and consenting to participate in the study shall be enrolled.
2. Dry eye shall be diagnosed based on Ocular Surface Disease Index (OSDI) score greater than 13, and TBUT < 10 seconds or Schirmer I score <10 mm.
|
|
| ExclusionCriteria |
| Details |
1. Patients with severe dry eye ; OSDI>33
2. Schirmer I test less than 5 mm in either eye at screening.
3. Patients with any uncontrolled severe systemic disease that may affect the eye (other than Diabetes Mellitus).
4. Patients with use of any systemic medication that may affect tear film or vision within 3 months of screening .
5. Any ocular/ophthalmic surgery or trauma, which could affect corneal sensitivity and/or tear distribution within 6 months prior to screening.
6. Current or previous use of topical ocular medication within 2 weeks of screening and use of contact lens anticipated during the study or use 3 months prior to screening.
7. Patients with raised intraocular pressure on screening and known cases of glaucoma shall also be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| OSDI symptom score |
At 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in ocular surface stabilty ( TBUT, Schirmer,lipid layer thickness, tear meniscus height)
Meibography
Corneal nerve morphology on confocal microscopy
Tear Osmolarity
Tear inflammatory cytokine levels
Tear glucose levels |
At 6 months |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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 2 |
|
Date of First Enrollment (India)
|
01/12/2021 |
| 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="3"
Months="3"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The long-term effects of topical insulin on ocular surface parameters, dry eye symptomatology and tear biochemical markers in mild-moderate dry eye patients with diabetes has not been studied. Topical Insulin therapy may have a role in improving the nerve density, health of the corneal epithelial cells, lacrimal gland and meibomian gland function ultimately leading to a better tear film and stability of the diabetic ocular surface.Topical insulin therapy may improve lacrimal gland function, tear film stability, meibomian gland and dry eye symptomatology in diabetic patients with dry eye disease.The study aims to evaluate the impact of topical Insulin therapy on the dry eye related symptomatology, ocular surface parameters, tear inflammatory markers and tear biochemical parameters in diabetic dry eye patients
|