| CTRI Number |
CTRI/2025/01/079391 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of Lactoferrin tablets in post refractive surgery dry eye. |
|
Scientific Title of Study
|
To study the impact of oral administration of lactoferrin in post refractive surgery dry eye. |
| 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 Namrata Sharma |
| Designation |
Professor Of Ophthalmology |
| Affiliation |
AIIMS |
| Address |
Room No 495, Fourth Floor, Dr R P Centre, AIIMS
Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9810856988 |
| Fax |
|
| Email |
namrata.sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namrata Sharma |
| Designation |
Professor Of Ophthalmology |
| Affiliation |
AIIMS |
| Address |
Room No 495, Fourth Floor, Dr R P Centre, AIIMS
Ansari Nagar, New Delhi
DELHI
110029
India |
| Phone |
9810856988 |
| Fax |
|
| Email |
namrata.sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namrata Sharma |
| Designation |
Professor Of Ophthalmology |
| Affiliation |
AIIMS |
| Address |
Room No 495, Fourth Floor, Dr R P Centre, AIIMS
Ansari Nagar, New Delhi
DELHI
110029
India |
| Phone |
9810856988 |
| Fax |
|
| Email |
namrata.sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
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 Namrata Sharma |
AIIMS |
Room no 494, Fourth
Floor, Dr R P Centre for
Ophthalmic Sciences,
AIIMS, Ansari Nagar,
New Delhi 110029
South
DELHI |
9810856988
namrata.sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H521||Myopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lactoferrin |
Lactoferrin is a globular glycoprotein used as a
nutritional supplement. Lactoferrin tablets (100mg) will be given
after refractive surgery for 2
times a day for 3 months. |
| Comparator Agent |
Maltodextrin (Placebo) |
Maltodextrin is an
oligosaccharide used as
a food ingredient.
Maltodextrin tablets (100mg) will be
given post refractive surgery 2 times a day for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing refractive surgery.
2.Willingness to sign
written informed consent and follow up. |
|
| ExclusionCriteria |
| Details |
1.Patients with a history of ocular surgery other
than refractive surgery.
2.Pregnancy and feeding mothers.
3.Lactose intolerance or cow milk allergy.
4.Patients not willing for participate and follow
ups. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence of post refractive surgery dry eye
comes to 10% from 35% at 6 month post surgery |
Prevalence of post refractive surgery dry eye
comes to 10% from 35% at 6 month post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bioavailability of lactoferrin in tear film |
Tear samples will be collected at baseline,
before surgery then 1 month, 3 month and 6
month post refractive surgery |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| 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 - NO
|
|
Brief Summary
|
This study aims to evaluate the dry eye induced by refractive surgery and the effect of oral lactoferrin on the post refractive surgery dry eye. Refractive surgeries are known to induce postoperative dry eye, furthermore, the inflammation caused by the surgery, the distortion of the ocular surface and preservative in the eye drops used post-operatively, all exacerbate the condition. Lactoferrin, a glycoprotein present in the tears, has several functions, including anti-inflammatory, antimicrobial and as well as promotion of cell growth. Lactoferrin treatment for the post refractive surgery dry eye proves to be significant by this study and we will be able to develop a feasible and reliable nutritional supplement for dry eye. |