Health Condition 1: H533- Other and unspecified disorders ofbinocular vision
Conditions
Interventions
Intervention1: CAEP-01: Dose: 44 mg/day containing 4 mg of Astaxanthin
Route: orally
Regimen: one capsule before breakfast for 84 ± 3 days (preferably with milk/butter/ghee)
Control Intervention1: Ol
Sponsors
Vedic Lifesciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: ? 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Immunity as assessed by the number of sick days reported for each participant during the treatment period, as compared to the placeboTimepoint: Day 14, Day 28, Day 56 and Day 84;Immunity as assessed by the number of times participant has contracted the common cold/flu during the treatment period, as compared to the placeboTimepoint: Day 14, Day 28, Day 56 and Day 84;To evaluate the efficacy of 84 days of IP consumption on Change in visual fatigue as assessed by Asthenopia Visual Fatigue Likert scaleTimepoint: Day 0, Day 14, Day 28, Day 56 and Day 84 before and after playing 50±10 min of videogame on digital device;To evaluate the efficacy of 84 days of IP consumption onVisual acuity as assessed by Digital Eye Strain battery (DESB) consisting of 1 Visual Acuity 2 Spherical Equivalence 3 Near point accommodation 4 Near exophoria 5 Dry eyes intensity 6 Pupil Size 7 Stereopsis 8 Blinking frequencyTimepoint: Day 0, Day 14, Day 28, Day 56 and Day 84 after playing 50±10 min of Videogame on digital device | — |
Countries
India
Contacts
Public ContactDr Sonal Raote
Vedic Lifesciences Pvt Ltd
Outcome results
None listed