| CTRI Number |
CTRI/2025/11/098039 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical Study on Lutein and Zeaxanthin 164 for Reducing Eye Fatigue and Dry Eyes in Healthy Subjects. |
|
Scientific Title of Study
|
A Randomized, Double-blind, Placebo-controlled, Three-arm Clinical Study to Evaluate the Modulatory Effect of Lutein Zeaxanthin 164 Supplementation on Eye Fatigue as well as Dry Eyes in Healthy Subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RRS/CL/EY/DE/2025 Version Number: 1.0 Date: 23 Jul 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Dakshayini |
| Designation |
Principal Investigator |
| Affiliation |
The Oxford Medical College, Hospital and Research Centre |
| Address |
Department of Ophthalmology Yadavanahalli, Attibele Hobli, Anekal Taluk, Bangalore-562107
Bangalore
KARNATAKA
562107
India |
| Phone |
9448206041 |
| Fax |
|
| Email |
drdakshayinim@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. Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru- 560058,Karnataka, India
Bangalore
KARNATAKA
560058
India |
| Phone |
9880999297 |
| 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. Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru- 560058,Karnataka, India
Bangalore
KARNATAKA
560058
India |
| Phone |
9880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
|
Source of Monetary or Material Support
|
| M/s. NUTRIONE 21~23F, Olympic-ro, 35da-gil Songpa-gu, Seoul, Republic of Korea
|
|
|
Primary Sponsor
|
| Name |
Nutrione |
| Address |
21~23F,Olympic-ro, 35da-gil Songpa-gu, Seoul, Republic of Korea |
| Type of Sponsor |
Other [Nutraceutical supplement company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr H N Shivaprasad |
Botanic Healthcare Pvt Ltd
TSIIC Industrial Development Area, Plot-16/1/12 and 13 Nacharam(V), Uppal(M), Hyderabad,Telangana 500076, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M Dakshayini |
The Oxford Medical College, Hospital and Research Centre |
Department of Ophthalmology Yadavanahalli, Attibele Hobli, Anekal Taluk, Bangalore-562107
Bangalore
KARNATAKA |
09448206041
drdakshayinim@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee The Oxford Medical College, Hospital & Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lutein and Zeaxanthin 20 mg |
Dose :500mg,Doasge form:Capusle, Duration 90 days, 1 capsule per day in the morning with breakfast. |
| Intervention |
Lutein and Zeaxanthin 40 mg |
Dose :500mg,Doasge form:Capusle, Duration 90 days, 1 capsule per day in the morning with breakfast |
| Comparator Agent |
Placebo |
Dose :500mg,Doasge form:Capusle, Duration 90 days, 1 capsule per day in the morning with breakfast |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy Volunteers
2.Volunteers of either sex, with age 18 to 65 years
3.Those who use the monitor for more than 4 hours/day
4.Those who can use glasses without lenses of 1.0 diopter or more
5.Eye fatigue: Slight to Moderate (using VAS-F questionnaire)
|
|
| ExclusionCriteria |
| Details |
A. Medication Use:
1.People with drug addiction
2.People who regularly use ophthalmic eye drops
3.People who use artificial tears more than 7 times per day
4.People taking medications that may affect dry eye symptoms, such as: Treatments for autoimmune diseases or thyroid disorders, Antihistamines, Beta-blockers, Tricyclic antidepressants, Estrogen therapy
5.People undergoing hormone replacement therapy
B. Disease Conditions:
6.People diagnosed with dry eye syndrome
7.People with chronic diseases
8.People with Sjogren’s syndrome
9.People with a history of eye surgery
10.People with other ophthalmic diseases besides dry eye syndrome, including those undergoing retinal surgery or retinal laser treatment
11.People with pollen allergies or chronic asthma
12.People with Meibomian gland dysfunction
13.People with uncontrolled hypertension SBP greater than 140 mmHg or DBP greater than 90 mmHg
14.People with uncontrolled diabetes HbA1c greater than 7.0 percent.
15.People with rheumatoid arthritis
16.People with sleep disorders
C. Other General Conditions (Physiological, Lifestyle, Allergic Reactions, etc.)
17.Contact lens users who wear lenses more than 3 days per week
18.Pregnant or breastfeeding women, or those planning to become pregnant
19.People with known allergies or adverse reactions to the investigational product
20.People with excessive alcohol consumption-
Men greater than or equal to 40 g per day and Women greater than or equal to 20g per day, According to WHO daily alcohol intake guidelines
21.Heavy smokers- greater than or equal to 20 cigarettes per day
22.People who regularly take supplements or health functional foods
23.People who have taken functional foods related to eye health within the past 3 months
24.People who have participated in another clinical trial within the past 3 months
25.People deemed unsuitable for the study by the investigator’s judgment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome:
1.Tear production by Schirmer’s test
2.Improvement in tear film stability, measured by tear film break up time (TFBUT)
3.Improvement in visual fatigue, assessed by Flicker Test
|
Day 0, Day 45 , Day 90
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcome:
1.To assess the safety of Lutein Zeaxanthin 164 through safety assessments like, hematology, and biochemistry (LFT and RFT) (Screening and Day 90)
2.Reduction in Subjective Symptoms evaluated using a visual analog scale (VAS) for dryness, irritation, and discomfort
3.Ocular Surface Disease Index (OSDI) Score
4.Change in eye fatigue levels by CVS Score
5.Change in eye fatigue levels VAS-F Assessment
6.Changes in Lutein and Zeaxanthin plasma concentrations
|
Day 0, Day 45 , Day 90 |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/12/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Eye fatigue, also known as asthenopia or computer vision syndrome (CVS), and dry eye syndrome, or keratoconjunctivitis sicca, are ocular conditions often associated with prolonged visual tasks, particularly digital screen use (>4 hours/day). Eye fatigue is characterized by eye strain, discomfort, blurred vision, double vision, and headaches, driven by reduced blink rates and environmental factors such as low humidity. Dry eye syndrome involves insufficient tear production or poor tear quality, leading to dryness, irritation, a gritty sensation, redness, and intermittent blurred vision, resulting from tear film instability. Eye fatigue and dry eye syndrome, if persistent, can lead to several complications that impact ocular health and overall well-being. Prolonged eye fatigue may result in chronic eye strain, worsening visual discomfort, and reduced visual acuity, potentially contributing to headaches and decreased productivity. Dry eye syndrome, characterized by tear film instability, can cause corneal irritation, superficial punctate keratitis, or, in severe cases, corneal abrasions, increasing the risk of ocular infections. Prolonged screen exposure has become a routine part of modern life, leading to a rise in symptoms such as eye fatigue and dry eyes. These symptoms are especially common in individuals who use digital devices for extended periods each day. Factors such as reduced blink rate, prolonged visual focus, and environmental stressors contribute to discomfort, visual strain, and tear film instability. While lubricating eye drops offer temporary relief, they do not address underlying causes like oxidative stress or light- induced damage. Nutritional supplementation, particularly with Lutein and Zeaxanthin, has emerged as a promising approach. These carotenoids are known to filter blue light and reduce oxidative stress in the eye, supporting visual performance and ocular comfort and Existing evidence supports the role of Lutein and Zeaxanthin in improving contrast sensitivity, glare tolerance, and visual processing |