| CTRI Number |
CTRI/2025/03/083269 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical trail on Eye health with Keratoconjunctivitis Sicca |
|
Scientific Title of Study
|
A Randomized, Double-Blind, two-arm, placebo-Controlled Study to
Evaluate the Efficacy and Safety of Lutein 10mg, Meso zeaxanthin 10mg with
Zeaxanthin 2mg in Subjects with Keratoconjunctivitis Sicca. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RRS/CL/LMZ/KCS/2024 Version: 1.0 Date: 29 November 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd |
| Address |
RADIANT RESEARCH SERVICES PVT LTD.
NO.99/A, 8th Main Road, 3rd Phase,
Peenya Industrial Area, Bengaluru-560 068
Karnataka, India.
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd |
| Address |
Radiant Research Services Pvt Ltd.
NO.99/A, 8th Main Road, 3rd Phase,
Peenya Industrial Area, Bengaluru-560 068
Karnataka, India.
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd |
| Address |
Radiant Research Services Pvt Ltd.
NO.99/A, 8th Main Road, 3rd Phase,
Peenya Industrial Area, Bengaluru-560 068
Karnataka, India.
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ingex Botanicals Private Limited
No.508, Medini, 60 ft road
F Block, Sahakarnagar, Bengaluru-560092,
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
INGEX BOTANICALS PRIVATE LIMITED |
| Address |
No.508, Medini, 60 ft road
F Block, Sahakarnagar, Bengaluru-560092,
Karnataka, India. |
| Type of Sponsor |
Other [ [Nutraceutical supplement company]] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Bio Actives Japan KK |
4-1-1, BAJ Bldg., Minami-Nagasaki, Toshima-Ku, Tokyo, JAPAN -171-0052 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P Seshu babu |
Government medical College and Government General Hospital(Old RIMSGGH) |
Government medical College and Government General Hospital,
Srikakulam-532001, Andhra Pradesh, India
Srikakulam
ANDHRA PRADESH |
9493905251
drseshubabupggh@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government medical College and Government General Hospital Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H04||Disorders of lacrimal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Starch |
Dose:22mg Dosing Frequency: capsules, Duration: 90 days One capsule orally in the morning after Break fast |
| Intervention |
Lutein
Meso Zeaxanthin
Zeaxanthin |
Dose:22 mg Dosing Frequency: capsules, Duration: 90 days One capsule
orally in the
morning after
Break fast |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Indian volunteers aged between 18 to 55 years.
2. Confirmed diagnosis of keratoconjunctivitis sicca.
3. Participants must have a Tear Film Breakup Time (TBUT) of less
than 10 seconds.
4. Participants must have a Schirmer’s test score of 10 mm or less
of wetting after 5 minutes.
5. Participants must have an Ocular Surface Disease
6. Index (OSDI) score of 13 or higher.
7. Normal Lid position and closure.
8. Willing to give written Informed Consent. |
|
| ExclusionCriteria |
| Details |
1. Pregnant, Breastfeeding, subjects undergone any surgery and
else take taken part in any clinical Trial.
2. Not willing to Sign the ICF or give the consent
3. History of hypersensitivity to lutein or zeaxanthin.
4. Unwilling to avoid wearing contact lenses for the entire duration
of the study.
5. Use of systemic or topical corticosteroids within 30 days prior to
screening.
6. History of ocular surgery within the past 6 months.
7. Any other condition that, in the opinion of the investigator,
would interfere with the study assessments or safety.
8. Participation in another clinical trial during the study period. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Endpoints:
1.Changes in Tear film break-up (TFBU).
2.Changes in Schirmer’s test.
3.Changes in OSDI Questionnaire |
Screening Visit, Day 45 and Day 90. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Endpoints:
1.To assess the safety of the product through safety Assessment(Screening Visit and Day 90)
2.Serum MMP-9 levels(Day 0,Day 45 and Day 90)
3.QOL questionnaire.
4.Ocular discomfort score. |
Screening Visit, Day 0, Day 45 and Day 90 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
07/04/2025 |
| Date of Study Completion (India) |
17/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Lutein Lutein is a type of carotenoid, which are pigments found in plants. It’s known for its strong antioxidant properties and is often referred to as "the eye vitamin" due to its benefits for eye health2. Lutein is concentrated in the retina, particularly in the macula, which is responsible for central vision. It helps filter harmful blue light and protects the eyes from oxidative stress, reducing the risk of age-related macular degeneration (AMD) and cataracts3. Additionally, lutein may support cognitive function and heart health. Meso-zeaxanthin is another carotenoid found in the macula. It’s less common in the diet and is often synthesized in the body from other carotenoids3. Meso-zeaxanthin works alongside lutein and zeaxanthin to form the macular pigment, which protects the eyes from blue light and oxidative damage. It’s believed to improve ocular blood flow and reduce the risk of AMD. Zeaxanthin is similar to lutein and is also found in the macula. It has potent antioxidant properties and helps protect the eyes from harmful light and oxidative stress3. Zeaxanthin is concentrated in the center of the retina, while lutein is found in the peripheral regions. Together, they form the macular pigment, which is crucial for maintaining sharp vision and reducing the risk of eye diseases like AMD and cataracts.
Lutein, meso-zeaxanthin and zeaxanthin are carotenoids that play a significant role in eye health, particularly in managing Keratoconjunctivitis Sicca (KCS). These nutrients are known for their antioxidant and anti-inflammatory properties, which help protect the eyes from oxidative stress and inflammation. Lutein and zeaxanthin are concentrated in the macula, the central part of the retina, where they help filter harmful blue light and neutralize free radicals. This reduces oxidative stress, which can exacerbate dry eye symptoms. These carotenoids have been shown to reduce inflammation in the ocular surface, which is beneficial for managing the symptoms of KCS. Also, it enhances the overall health of the ocular surface, lutein, meso-zeaxanthin, and zeaxanthin can contribute to better tear film stability, reducing tear evaporation and dryness. The Supplementation with these carotenoids has been associated with improved visual performance, including better contrast sensitivity and visual acuity. |