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

Study Overview
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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.

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

Conditions
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Vision Disorders

Intervention / Treatment
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* Other: CAEP-01
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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: Participant with CVS-Q score ≥ 19. Asthenopia Visual Fatigue Likert Scale Score ≤ 2 for each symptom. Near Point Convergence (NPC) no further than 10 cm Stereopsis of ≥ 40 arc/sec Not diagnosed with amblyopia Refractive error less than -3 or more than +2 Participants who wear contact lenses. Participants with any diagnosed ocular motility disorder or accommodative/binocular vision issues. Participants with a history of eye alignment or binocularity issues. Participants who are color-blind. Participant on any antioxidant, retinols and carotenoid supplements. Participants who have used eye care products within 3 months prior to the screening visit. Participants who have been diagnosed with Type I diabetes. Participants who have been diagnosed with Covid-19 one month before the screening visit. Participants scheduled to receive any vaccination during the study period. Participants who have immunosuppressive disorders or are taking immunosuppressive medication.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CAEP-01<br>Dose: 1 capsule Route: orally for 84 ± 3 days Regimen: one capsule beforebreakfast (preferably with milk/butter/ghee) | Other: CAEP-01<br>* Dose: 1 capsule Route: orally for 84 ± 3 days Regimen: one capsule before breakfast (preferably with milk/butter/ghee)<br>|
| Placebo Comparator: Placebo<br>Dose: 1 capsule Route: orally for 84 ± 3 Regimen: one capsule before breakfast (preferably with milk/butter/ghee) | Other: Placebo<br>* Dose: 1 capsule Route: orally for 84 ± 3 days Regimen: one capsule before breakfast (preferably with milk/butter/ghee)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Computer Vision Syndrome-Questionnaire | To assess the effect of 84 days of IP consumption on severity of the symptoms using Computer Vision Syndrome-Questionnaire.The two levels of intensity, or strength of the symptom, will be graded similarly, on a scale of 1 to 2 points, where moderate = 1 and intense = 2. In the analysis, a symptom rated as never occurring will be treated as 0 (none) on the intensity scale. The overall assessment will be conducted by obtaining the total score for DES. The result of frequency X intensity will be recorded as: 0 = 0; 1 or 2 = 1; 4 = 2. If the total score is ≥ 6 points, the participant will be considered to be suffering from digital eye strain. It is further categorized as mild DES (score = 6-12), moderate DES (score = 13-18), and severe DES (score = 19-32) | Screening before playing videogames on digital device | 
| Computer Vision Syndrome-Questionnaire | To assess the effect of 84 days of IP consumption on severity of the symptoms using Computer Vision Syndrome-Questionnaire.The two levels of intensity, or strength of the symptom, will be graded similarly, on a scale of 1 to 2 points, where moderate = 1 and intense = 2. In the analysis, a symptom rated as never occurring will be treated as 0 (none) on the intensity scale. The overall assessment will be conducted by obtaining the total score for DES. The result of frequency X intensity will be recorded as: 0 = 0; 1 or 2 = 1; 4 = 2. If the total score is ≥ 6 points, the participant will be considered to be suffering from digital eye strain. It is further categorized as mild DES (score = 6-12), moderate DES (score = 13-18), and severe DES (score = 19-32) | Day 0 before playing videogames on digital device | 
| Computer Vision Syndrome-Questionnaire | To assess the effect of 84 days of IP consumption on severity of the symptoms using Computer Vision Syndrome-Questionnaire.The two levels of intensity, or strength of the symptom, will be graded similarly, on a scale of 1 to 2 points, where moderate = 1 and intense = 2. In the analysis, a symptom rated as never occurring will be treated as 0 (none) on the intensity scale. The overall assessment will be conducted by obtaining the total score for DES. The result of frequency X intensity will be recorded as: 0 = 0; 1 or 2 = 1; 4 = 2. If the total score is ≥ 6 points, the participant will be considered to be suffering from digital eye strain. It is further categorized as mild DES (score = 6-12), moderate DES (score = 13-18), and severe DES (score = 19-32) | Day 14 before playing videogames on digital device | 
| Computer Vision Syndrome-Questionnaire | To assess the effect of 84 days of IP consumption on severity of the symptoms using Computer Vision Syndrome-Questionnaire.The two levels of intensity, or strength of the symptom, will be graded similarly, on a scale of 1 to 2 points, where moderate = 1 and intense = 2. In the analysis, a symptom rated as never occurring will be treated as 0 (none) on the intensity scale. The overall assessment will be conducted by obtaining the total score for DES. The result of frequency X intensity will be recorded as: 0 = 0; 1 or 2 = 1; 4 = 2. If the total score is ≥ 6 points, the participant will be considered to be suffering from digital eye strain. It is further categorized as mild DES (score = 6-12), moderate DES (score = 13-18), and severe DES (score = 19-32) | Day 28 before playing videogames on digital device | 
| Computer Vision Syndrome-Questionnaire | To assess the effect of 84 days of IP consumption on severity of the symptoms using Computer Vision Syndrome-Questionnaire.The two levels of intensity, or strength of the symptom, will be graded similarly, on a scale of 1 to 2 points, where moderate = 1 and intense = 2. In the analysis, a symptom rated as never occurring will be treated as 0 (none) on the intensity scale. The overall assessment will be conducted by obtaining the total score for DES. The result of frequency X intensity will be recorded as: 0 = 0; 1 or 2 = 1; 4 = 2. If the total score is ≥ 6 points, the participant will be considered to be suffering from digital eye strain. It is further categorized as mild DES (score = 6-12), moderate DES (score = 13-18), and severe DES (score = 19-32) | Day 56 before playing videogames on digital device | 
| Computer Vision Syndrome-Questionnaire | To assess the effect of 84 days of IP consumption on severity of the symptoms using Computer Vision Syndrome-Questionnaire.The two levels of intensity, or strength of the symptom, will be graded similarly, on a scale of 1 to 2 points, where moderate = 1 and intense = 2. In the analysis, a symptom rated as never occurring will be treated as 0 (none) on the intensity scale. The overall assessment will be conducted by obtaining the total score for DES. The result of frequency X intensity will be recorded as: 0 = 0; 1 or 2 = 1; 4 = 2. If the total score is ≥ 6 points, the participant will be considered to be suffering from digital eye strain. It is further categorized as mild DES (score = 6-12), moderate DES (score = 13-18), and severe DES (score = 19-32) | Day 84 before playing videogames on digital device | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthenopia Visual Fatigue Likert scale | The participant will respond digitally a relevant present condition from None (0), Very Mild (1), Mild (2), Moderate (3), Very Moderate (4), and Severe (5) and the total score will be calculated | Day 0, day 14, day 28, day 56 and day 84. | 
| Immunitythe subject felt sick will be documented in sick diary along with the concomitant medication used (dose and frequency will be captured). | the number of days when the subject felt sick will be documented in sick diary along with the concomitant medication used (dose and frequency will be captured). Immunity as assessed by the number of sick days reported for each participant during the treatment period, as compared to the placebo | Day 14, Day 28, Day 56 and Day 84 | 
| Immunity of participan has contracted the common cold/flu | Immunity as assessed by the number of times participant has contracted the common cold/flu during the treatment period, as compared to the placebo. | Day 14, Day 28, Day 56 and Day 84 |