| CTRI Number |
CTRI/2025/02/080686 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| 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 trial on Dry eye symptoms |
|
Scientific Title of Study
|
A randomized double-blind placebo-controlled clinical study for the comparative evaluation of efficacy and tolerability of XanMax® 2002 in adult subjects with dry eye symptoms |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| XanMax2002/Dry-Eye/2024 Version 1.0 dated 24th October 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Seshu Babu |
| Designation |
Principal investigator |
| Affiliation |
Government Medical College and Hospital (RIMS) |
| Address |
Department of Ophthalmology
Ground Floor Room number 2
Government Medical College and Hospital HUDCO Colony, Balaga Srikakulam
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
9493905251 |
| Fax |
|
| Email |
drseshubabupggh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Priya M K |
| Designation |
Sr.VP-Carotenoid Business |
| Affiliation |
Katra Phytochem (India) Pvt Ltd |
| Address |
Plant No. 7, A-1, Attibele Industrial Area,Anekal Taluk, Bangalore District Karnataka, India
Bangalore
KARNATAKA
562107
India |
| Phone |
09844593322 |
| Fax |
|
| Email |
priya@katraphyto.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Priya M K |
| Designation |
Sr.VP-Carotenoid Business |
| Affiliation |
Katra Phytochem (India) Pvt Ltd |
| Address |
Plant No. 7, A-1, Attibele Industrial Area,Anekal Taluk, Bangalore District Karnataka, India
KARNATAKA
562107
India |
| Phone |
09844593322 |
| Fax |
|
| Email |
priya@katraphyto.com |
|
|
Source of Monetary or Material Support
|
| Daehan Chemtech CO., LTD. B-1208, 65, Gwacheon-daero 7-gil Gwacheon-si, Gyeonggi-do
13840, South Korea |
| Katra Phytochem (India) Private Limited Plant No. 7, A-1, Attibele Industrial Area, Anekal Taluk,
Bangalore District – 562107, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Katra Phytochem (India) Private Limited |
| Address |
Plant No. 7, A-1, Attibele Industrial Area, Anekal Taluk, Bangalore District – 562107, Karnataka, India |
| Type of Sponsor |
Other [Nutraceutical supplement company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Daehan Chemtech CO LTD |
B-1208, 65, Gwacheon-daero 7-gil Gwacheon-si, Gyeonggi-do 13840, South Korea |
|
|
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 Hospital (old RIMS) |
Department of Ophthalmology
Ground Floor Room number 2
Government Medical College and Hospital HUDCO Colony, Balaga Srikakulam
Srikakulam
ANDHRA PRADESH |
09493905251
drseshubabupggh@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee – Government medical college and Government General hospital (Old RIMS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H048||Other disorders of lacrimal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Dose: 300 mg Dosage form: soft gel capsule Route of administration: Oral Frequency: One capsule orally 30 minutes after breakfast Duration: 90 days
|
| Intervention |
XanMax® 2002 oil
Lutein and zeaxanthin in ratio of 10:1 |
Dose: 300 mg
(Each soft gel capsule contains Lutein and zeaxanthin in ratio of 10:1 from XanMax® 2002 oil)
Dosage form:soft gel capsule
Route of administration: Oral
Frequency: One capsule orally 30 minutes
after breakfast
Duration: 90 days
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female participants aged 40 to 75 years.
2. Participants who spend at least four hours per day engaged in screen-based activities (e.g., watching television, using a computer, laptop, or other digital devices).
3. Participants reporting symptoms of dry eye, such as irritation, pain, or itching, along with vision-related symptoms such as glare.
4. Participants with a tear break-up time (TBUT) of less than 10 seconds, as measured during screening.
5. Willingness and ability to attend scheduled follow-up visits and comply with the study protocol.
6. Ability to provide written informed consent prior to participation
|
|
| ExclusionCriteria |
| Details |
1. Diagnosis of any significant ophthalmic disease.
2. Presence of ocular conditions, including but not limited to cataracts, corneal diseases, ocular surface disorders, glaucoma, retinal diseases, or severe myopia (mild to moderate myopia is permitted).
3. History of eye surgery or regular use of contact lenses for more than three days per week.
4. Diagnosis of any recent or uncontrolled medical conditions, including but not limited to hypertension, diabetes mellitus, cardiovascular disease, gastrointestinal disorders, gallbladder disease, rheumatoid arthritis, other autoimmune diseases, endocrine disorders, or active malignancy.
5. History or diagnosis of psychiatric or neurological conditions, excluding mild to moderate depression or anxiety.
6. Regular use of medications known to affect ocular health or study outcomes, including but not limited to corticosteroids, hormone replacement therapy, antihistamines, beta-blockers, tricyclic antidepressants, or ocular medications such as eye drops.
7. Recent changes in medication regimen within the past three months or an expectation to change medications during the study period.
8. Current use of vitamins, lutein, zeaxanthin, or other supplements that may interfere with study outcomes.
9. History of illicit drug use within the past 12 months or alcohol consumption exceeding 14 standard drinks per week.
10. Pregnant or breastfeeding women or those planning to conceive within six months of the study start date.
11. History of significant surgery within the past 12 months.
12. Planned major lifestyle changes (e.g., relocation, job changes) during the study period.
13. Use of artificial tears more than seven times per day.
14. Diagnosis of Sjögren’s syndrome or any other systemic condition associated with dry eye disease.
15. Individuals working regular late-night shifts.
16. Any condition that, in the opinion of the Principal Investigator, may interfere with the participant’s ability to comply fully with the study protocol, pose a significant safety risk, or affect the interpretation of study results.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Ocular Surface Disease Index (OSDI): Change in OSDI scores from baseline to the end of the study, assessing symptoms of dry eye, visual function, and environmental triggers.
Tear Film Break-Up Time (TBUT): Change in TBUT from baseline to the end of the study, evaluating the stability of the tear film.
|
Screening Day 45 and Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Visual Analog Scale (VAS) for Pain: Change in subjective pain scores on a 0 to 100 mm VAS scale from baseline to study completion.
2. Visual Fatigue Scale (VFS): Change in visual fatigue scores from baseline, measuring eye strain and discomfort during screen use.
3. Schirmer Tear Test (STT): Change in tear production (measured in mm) from baseline using the Schirmer test.
4. Meibomian Gland Function: Assessment of changes in meibomian gland function, including gland secretion quality and expressibility
|
Day 0 and Day 90 |
5. Fluorescein Staining: Change in ocular surface staining scores (e.g., corneal or conjunctival) using fluorescein dye to assess epithelial damage.
6. Computer Vision Syndrome Questionnaire (CVS Q): Change in CVS Q scores from baseline, evaluating symptoms of digital eye strain
7. Photostress Recovery Time (PSRT): Change in the time required to recover vision following exposure to bright light
8. Inflammatory Biomarkers: Changes in tear or serum levels of inflammatory cytokines, including interleukin 1beta(IL 1beta), interferon-gamma (IFN gama), and tumor necrosis factor-alpha (TNF alpha).
9. Oxidative Stress Biomarkers: Changes in tear or serum levels of oxidative stress markers, including reactive oxygen species (ROS) and superoxide dismutase (SOD).
|
Day 0 and Day 90 |
Safety – Basic hematology biochemistry parameters and urine analysis
|
Day 0 and Day 90 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
28/02/2025 |
| Date of Study Completion (India) |
31/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
Building on the robust preclinical
and clinical evidence, the current study aims to evaluate the efficacy and
tolerability of XanMax® 2002, a novel formulation containing lutein and
zeaxanthin, in adult subjects with DED. The present study is designed to
confirm the efficacy and safety of lutein and zeaxanthin with the study
title—“A randomized double-blind placebo-controlled clinical
study for the comparative evaluation of efficacy and tolerability of XanMax®
2002 in adult subjects with dry eye symptoms.” |