To Evaluate the Efficacy and Safety of CAEP-01 on Eye Strain in Children With Heavy Screen Use

Vedic Lifesciences

Status: Completed

Conditions: Vision Disorders

Treatments: Other: CAEP-01; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05602402

AP/220201/CAEP/ES

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 10 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

CAEP-01

Active Comparator group

Description:

Dose: 1 capsule Route: orally for 84 ± 3 days Regimen: one capsule beforebreakfast (preferably with milk/butter/ghee)

Treatment:

Other: CAEP-01

Placebo

Placebo Comparator group

Description:

Dose: 1 capsule Route: orally for 84 ± 3 Regimen: one capsule before breakfast (preferably with milk/butter/ghee)

Treatment:

Other: Placebo