None listed
Conditions
Interventions
Intervention1: LN24214 200 mg/day: One capsule daily in the morning after breakfast for 42 days
Control Intervention1: Placebo: One capsule daily in the morning after breakfast for 42 days
Sponsors
Laila Nutra private limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female adults age between 30-50 years with BMI of 20 to 29 kg per meter square. 2. Self-reported average daily digital screen time of greater than or equal to 4 hours per day for the last greater than or equal to 3 months. 3. Participants who have complained of eye strain on use of digital device. 4. Participant with CVS-Q score between 8 and 19. 5. Best Corrected Visual Acuity BCVA of 20/20. 6. Participants with less than or equal to12.5 cm and greater than or equal to 6 cm on Near Point Accommodation NPA test. 7. Participant agrees to maintain a record of screen time use throughout the study. 8. Willing to participate in the study and was able to read and write. 9. Sign informed consent and complete all tests and procedures as listed in the protocol. 10. Females of childbearing potential who are sexually active must agree to use adequate non-hormonal contraception during the study. 11. Subject willing to maintain diet tracker and agrees to maintain current dietary habits through end of study period. 12. Subject agrees not to consume any supplements including beverages, herbal, vitamins Such as Folate, B12, and B6 containing multivitamins, drugs including OTC medications pain relievers, antihistamines, other allergy medications, cold/ flu remedies, prescriptions, recreational drugs and nutritional products during the study period. 13. Subject agrees to limit their intake of coffee less than or equal to 4 cups a day, tea less than or equal to 3 cups a day, cola greater than or equal to 3 cups a day, energy drinks less than or equal to 350 ml or 1.4 cans, chocolate less than 10 gms of dark chocolate. 14. Has not taken carotenoid supplements lutein, zeaxanthin, B-carotene, astaxanthin for 3 months. 15. Has not taken fish oils/omega oils for 2 weeks prior to study, and agrees to refrain for study duration. 16. Free from any clinically significant disease that might interfere with the study evaluations. 17. Has not taken any type of medicine/pharmaceutical supplements/ herbal supplements for the past 3 months related to improve eye health. 18. ECG without clinically significant abnormalities. 19. Results of screening are within normal range or considered not clinically significant by the Principal Investigator. 20. Subjects willing to refrain from using eye drops during the study period.
Exclusion criteria
Exclusion criteria: 1. Participants who wear contact lenses. 2. Participants with any diagnosed ocular motility disorder or accommodative/binocular vision issues. 3. Participants who are colour-blind. 4. Participant on any retinols and carotenoid supplements. 5. Participants who have immunosuppressive disorders or are taking immunosuppressive medication. 6. Participants with Atopy, allergic disorders and Anaemia. 7. Participants who underwent Ophthalmic laser treatment less than 3 months. 8. Women who are pregnant, lactating or planning to become pregnant during the study duration. 9. Subjects with a high blood pressure at screening systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 90 mmHg and fasting blood glucose levels greater than 125 mg/dl. 10. Systemic disease associated with dry eye or diagnosed with dry eye disease or Blepharitis. 11. Having liver chronic liver failure, cirrhosis, all types of hepatitis, kidney chronic kidney disease, haemodialysis or haematological anaemia, thalassemia, haemophilia disorders. 12. Psychiatric disease or mental retardation bipolar disorder, depression, schizophrenia. 13. Cancer all types, and endocrine disorders Cushings disease, gigantism and hyperthyroidism. 14. Subjects with the presence of severe dry eye syndrome, or with complications such as perforated corneal ulcer, uveitis, glaucoma, that may interfere with the evaluation of the subjects dry eye syndrome in the investigators opinion. 15. Subjects with herpetic eye disease, history of lacrimal gland infections, laser in situ keratomileusis and with any ocular trauma or surgery that may affect corneal sensitivity and/or normal tear distribution e.g., cataract surgery, refractive surgery within the 6 previous months to study inclusion. 16. Subjects with Sjogren syndrome. 17. Subjects with contraindication of pupil dilatation in the study eye. 18. Early or Mature cataract or media opacification in either eye which limits an adequate view of fundus. 19. Not willing to stop the use of ocular topical medications, steroids, any other medication and contact lenses during the intervention that may adversely affect the outcome of the study. 20. Subjects with diagnosed diabetes mellitus, rheumatoid arthritis, systemic lupus erythematous, which cause dry eye syndrome. 21. Subjects having history or signs of major systemic illness and with metabolic, renal, cardiac disorders. 22. Subject participating in another clinical trial or has received an investigational product or dietary supplement within thirty days prior to enrolment. 23. High alcohol intake greater than 2 std drinks per day, smoking cigarettes or use of recreational drugs such as cocaine, methamphetamine, marijuana, etc. 24. Subjects with congenital malformations. 25. Subject has any medical condition or uses any medication, nutritional product, protein powder, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk. 26. Subjects have known obstructive pulmonary disease or asthma or allergy to excipients of IP. 27. Subjects having post COVID symptoms or underwent treatment for COVID-19 within last 6 months or tested positive during the study will be excluded. 28. Subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from the baseline to end of the study period in: Scores of Computer vision syndrome (CVS) before digital exposure. Timepoint: Screening & Randomization (V1)-Day 1, Follow up Visit (V2)-Day 21 & Final Visit (V3)-Day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the scores of below tests before & after supplementation Visual fatigue scale questionnaire before & after 60 minutes of digital exposure. Timepoint: Day 1, Day 21, & Day 42;Change in the scores of below tests after 60 Minutes of Digital Exposure Visual Acuity Near Point Accommodation Near Exophoria Dry Eye Severity using the Schirmer I Test Pupil Size Stereopsis Blinking Frequency Instant Ocular Symptoms Survey Timepoint: Day 1, Day 21, & Day 42;Change in the scores of below tests before 60 Minutes of Digital Exposure Ocular Comfort Index Timepoint: Day 1, Day 21, & Day 42 | — |
Countries
India
Contacts
Public ContactMr Prason Kumar J
Laila Nutra Private Limited
Outcome results
None listed