To study the efficacy and safety of product on eye health in childrens
- Conditions
- Health Condition 1: H533- Other and unspecified disorders ofbinocular vision
- Registration Number
- CTRI/2022/10/046606
- Lead Sponsor
- Vedic Lifesciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
? Girls and Boys between the ages 10 to 14.
? Participants who have a history of using a digital device (phone, tablet, computer, etc) at least 4 hours per day, for minimum of last 3 months prior to screening.
? Participants who have complained of eye strain on use of digital device.
? Participant with CVS-Q score = 8.
? Participants who have history of playing video game for least 6 hours per week.
? Best Corrected Visual Acuity (BCVA) of 20/20
? Participants with = 12.5 cm and = 6 cm amplitude on accommodation test.
? Participants with parents who are literate enough to understand the essence of study, are informed about the purpose of the study, and understand their rights.
? Participants with parents who are able to give written informed consent and willingness to participate in the study and comply with its procedures.
1 Participant with CVS-Q score = 19.
2 Asthenopia Visual Fatigue Likert Scale Score = 2 for each symptom.
3 Near Point Convergence (NPC) no further than 10 cm
4 Stereopsis of = 40 arc/sec
5 Not diagnosed with amblyopia.
6 Refractive error less than -3 or more than +2
7 Participants who wear contact lenses.
8 Participants with any diagnosed ocular motility disorder or accommodative/binocular vision issues.
9 Participants with a history of eye alignment or binocularity issues.
10 Participants who are color-blind.
11 Participant on any antioxidant, retinols and carotenoid supplements.
12 Participants who have used eye care products within 3 months prior to the screening visit.
13 Participants who have been diagnosed with Type I diabetes.
14 Participants who have been diagnosed with Covid-19 one month before the screening visit.
15 Participants scheduled to receive any vaccination during the study period.
16 Participants who have immunosuppressive disorders or are taking immunosuppressive medication.
17 Participants with frequent history of cough and cold, at least once every month in last three months.
18 Allergic condition
19 Participants with known sensitivity to the investigational product or any excipients of the drug product.
20 Participants who refrain on discontinuing Vitamin supplementation during the study period.
21 Participants with history of any significant neurological and psychiatric condition which may affect the participation and inference of the study end points.
22 Participation in other clinical trials in last 3 months prior to screening.
23 Patients who have the following significant illness, i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, gastrointestinal diseases, etc.
24 Any condition that could, in the opinion of the investigator, preclude the participant’s ability to successfully and safely complete the study or that may confound study outcomes.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect of 84 days of IP consumption on severity of the symptoms using Computer Vision Syndrome-QuestionnaireTimepoint: Base line Day 0 and day 84
- Secondary Outcome Measures
Name Time Method