Clinical trial NCT05602402: To Evaluate the Efficacy and Safety of CAEP-01 on Eye Strain in Children With Heavy Screen Use
Official title: To Evaluate the Efficacy and Safety of CAEP-01 on Eye Strain in Children With Heavy Screen Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vision Disorders
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-02
Enrollment: 64
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: CAEP-01, Placebo Dose: 44 mg/day Route: orally for 84 ± 3 days Regimen: one capsule before breakfast (preferably with milk/butter/ghee)
Primary purpose: OTHER

Brief summary: Several recent clinical trials have highlighted the potential role of Product in promoting eye health.product whose structural and functional characteristics make it a promising bioactive compound in the prevention of several human diseases as well as in the maintenance of a good health status. it might relieve eyestrain in people using computer monitors as suggested who conducted a double-blind randomized clinical trial by enrolling visual display terminal workers and prescribed them product or placebo. Study outcomes were objectively evaluated by using a proper instrumentation to measure eye muscle endurance. Subjects receiving Product experienced a significant relief from eyestrain compared to the placebo group.


Eligibility criteria: Inclusion Criteria:

1. Girls and Boys between the ages 10 to 14.
2. 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.
3. Participants who have complained of eye strain on use of digital device.
4. Participant with CVS-Q score ≥ 8.
5. Participants who have history of playing video game for least 6 hours per week.
6. Best Corrected Visual Acuity (BCVA) of 20/20.
7. Participants with ≤ 12.5 cm and ≥ 6 cm amplitude on accommodation test.
8. 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.
9. 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:

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.

Primary outcomes:
measure: Computer Vision Syndrome-Questionnaire
timeFrame: Screening before playing videogames on digital device
measure: Computer Vision Syndrome-Questionnaire
timeFrame: Day 0 before playing videogames on digital device
measure: Computer Vision Syndrome-Questionnaire
timeFrame: Day 14 before playing videogames on digital device
measure: Computer Vision Syndrome-Questionnaire
timeFrame: Day 28 before playing videogames on digital device
measure: Computer Vision Syndrome-Questionnaire
timeFrame: Day 56 before playing videogames on digital device
measure: Computer Vision Syndrome-Questionnaire
timeFrame: Day 84 before playing videogames on digital device
Secondary outcomes:
measure: Asthenopia Visual Fatigue Likert scale
timeFrame: Day 0, day 14, day 28, day 56 and day 84.
measure: Immunitythe subject felt sick will be documented in sick diary along with the concomitant medication used (dose and frequency will be captured).
timeFrame: Day 14, Day 28, Day 56 and Day 84
measure: Immunity of participan has contracted the common cold/flu
timeFrame: Day 14, Day 28, Day 56 and Day 84
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Aman Hospital and Research Center
state: Guijarat
city: Thāne
country: India
facility: Wavikar Eye Institute
state: Maharashtra
city: Jaipur
country: India
facility: Jaipur National University Institute for Medical Sciences & Research Centre
state: Rajasthan
Study officials:
affiliation: Vedic Lifesciences Pvt. Ltd.
name: Dr Shalini Srivastava, MD medicine
role: PRINCIPAL_INVESTIGATOR
References: