| CTRI Number |
CTRI/2024/05/067780 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of oral lactoferrin 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 |
Chetan |
| Designation |
Ph.D scholar |
| Affiliation |
Dr R P Centre for Ophthalmic sciences, AIIMS, New Delhi. |
| Address |
Room no 494, Fourth Floor, Dr R P Centre for Ophthalmic Sciences, AIIMS, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
8447626012 |
| Fax |
|
| Email |
cazad79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namrata Sharma |
| Designation |
Professor Of Ophthalmology |
| Affiliation |
Dr R P Centre for Ophthalmic sciences, AIIMS, New Delhi. |
| Address |
Room no 494, Fourth Floor, Dr R P Centre for Ophthalmic Sciences, AIIMS, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9810856988 |
| Fax |
|
| Email |
namrata.sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chetan |
| Designation |
Ph.D scholar |
| Affiliation |
Dr R P Centre for Ophthalmic sciences, AIIMS, New Delhi. |
| Address |
Room no 494, Fourth Floor, Dr R P Centre for Ophthalmic Sciences, AIIMS, Ansari Nagar, New Delhi
DELHI
110029
India |
| Phone |
8447626012 |
| Fax |
|
| Email |
cazad79@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, Ansari Nagar, New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Dr R P Centre for Ophthalmic Sciences AIIMS |
| Address |
Room no- 495, Fourth Floor, Dr R P Centre for Ophthalmic Sciences, AIIMS, Ansari Nagar, New Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sujata Sharma |
Room no-9, Ground floor, Department of Biophysics, AIIMS, Ansari Nagar, New Delhi 110029 |
|
|
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 |
Dr R P Centre for Ophthalmic Sciences |
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 For Post Graduate Research, All India Institute of Medical Sciences, Ansari Nagar, New Delhi. |
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 multifunctional protein occurring in many biological secretions including milk. It is primarily extracted from bovine milk and used as a nutritional supplement. Oral Lactoferrin 100mg will be given after refractive surgery for 2 times a day for 2 months. |
| Comparator Agent |
Maltodextrin (Placebo) |
Maltodextrin is an oligosaccharide that is used as a food ingredient. Oral Maltodextrin 100mg will be given post refractive surgery 2 times a day for 2 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 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 |
Dry eye work up will be done at baseline, before refractive surgery then 1 week, 1 month, 3 month and 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)
|
03/06/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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. |