Health Condition 1: H048- Other disorders of lacrimal system
Conditions
Interventions
Intervention1: XanMax 2004 oil
Lutein and zeaxanthin
in ratio of 5:1: Dose: 300 mg (Each soft gel capsule contains Lutein and zeaxanthin in ratio of
5:1 from XanMax 2004 oil) Dosage form:soft gel
Sponsors
Katra Phytochem (India) Private Limited
Daehan Chemtech CO LTD
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 Sj gren 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.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. 2. Tear Film Break-Up Time (TBUT): Change in TBUT from baseline to the end of the study, evaluating the stability of the tear film.Timepoint: Screening Day 30 and Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Day 0 and Day 60;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). 10.Safety Basic hematology biochemistry parameters and urine analysisTimepoint: Day 0 and Day 60 | — |
Countries
India
Contacts
Public ContactMs Priya M K
Katra Phytochem (India) Pvt Ltd
Outcome results
None listed