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Completed

NCT Number: NCT05602402

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

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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Key information

Conditions

Vision Disorders Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aman Hospital and Research Center, Ahmedabad, Guijarat, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CAEP-01

Other

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

Placebo

Other

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

Primary outcomes

  1. Computer Vision Syndrome-Questionnaire

    Time frame: Screening before playing videogames on digital device

    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)

  2. Computer Vision Syndrome-Questionnaire

    Time frame: Day 0 before playing videogames on digital device

    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)

  3. Computer Vision Syndrome-Questionnaire

    Time frame: Day 14 before playing videogames on digital device

    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)

  4. Computer Vision Syndrome-Questionnaire

    Time frame: Day 28 before playing videogames on digital device

    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)

  5. Computer Vision Syndrome-Questionnaire

    Time frame: Day 56 before playing videogames on digital device

    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)

  6. Computer Vision Syndrome-Questionnaire

    Time frame: Day 84 before playing videogames on digital device

    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)

Secondary outcomes

  1. Asthenopia Visual Fatigue Likert scale

    Time frame: Day 0, day 14, day 28, day 56 and day 84.

    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

  2. Immunitythe subject felt sick will be documented in sick diary along with the concomitant medication used (dose and frequency will be captured).

    Time frame: Day 14, Day 28, Day 56 and Day 84

    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

  3. Immunity of participan has contracted the common cold/flu

    Time frame: 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 placebo.

Sponsors and collaborators

Lead sponsor

Vedic Lifesciences Pvt. Ltd.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2022
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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