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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-11

Study Completion Date

2023-04-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Vision Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

CAEP-01, Placebo Dose: 44 mg/day Route: orally for 84 ± 3 days Regimen: one capsule before breakfast (preferably with milk/butter/ghee)

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Sealed envelop, double-blind randomized

Study Groups

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CAEP-01

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

Group Type ACTIVE_COMPARATOR

CAEP-01

Intervention Type OTHER

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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CAEP-01

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

Intervention Type OTHER

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No