Back to resultsTo Evaluate the Efficacy and Safety of CAEP-01 on Eye Strain in Children With Heavy Screen Use
Primary Purpose
Vision Disorders
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
CAEP-01
Placebo
Sponsored by
About this trial
This is an interventional other trial for Vision Disorders
Eligibility Criteria
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.
Sites / Locations
- Aman Hospital and Research Center
- Wavikar Eye Institute
- Jaipur National University Institute for Medical Sciences & Research Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
CAEP-01
Placebo
Arm Description
Dose: 1 capsule Route: orally for 84 ± 3 days Regimen: one capsule beforebreakfast (preferably with milk/butter/ghee)
Dose: 1 capsule Route: orally for 84 ± 3 Regimen: one capsule before breakfast (preferably with milk/butter/ghee)
Outcomes
Primary Outcome Measures
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)
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)
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)
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)
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)
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)
Secondary Outcome Measures
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
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
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.
Full Information
NCT ID
NCT05602402
First Posted
October 17, 2022
Last Updated
April 25, 2023
Sponsor
Vedic Lifesciences Pvt. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05602402
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
April 24, 2023 (Actual)
Study Completion Date
April 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vedic Lifesciences Pvt. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vision Disorders
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
Sealed envelop, double-blind randomized
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAEP-01
Arm Type
Active Comparator
Arm Description
Dose: 1 capsule Route: orally for 84 ± 3 days Regimen: one capsule beforebreakfast (preferably with milk/butter/ghee)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dose: 1 capsule Route: orally for 84 ± 3 Regimen: one capsule before breakfast (preferably with milk/butter/ghee)
Intervention Type
Other
Intervention Name(s)
CAEP-01
Intervention Description
Dose: 1 capsule Route: orally for 84 ± 3 days Regimen: one capsule before breakfast (preferably with milk/butter/ghee)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Dose: 1 capsule Route: orally for 84 ± 3 days Regimen: one capsule before breakfast (preferably with milk/butter/ghee)
Primary Outcome Measure Information:
Title
Computer Vision Syndrome-Questionnaire
Description
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)
Time Frame
Screening before playing videogames on digital device
Title
Computer Vision Syndrome-Questionnaire
Description
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)
Time Frame
Day 0 before playing videogames on digital device
Title
Computer Vision Syndrome-Questionnaire
Description
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)
Time Frame
Day 14 before playing videogames on digital device
Title
Computer Vision Syndrome-Questionnaire
Description
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)
Time Frame
Day 28 before playing videogames on digital device
Title
Computer Vision Syndrome-Questionnaire
Description
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)
Time Frame
Day 56 before playing videogames on digital device
Title
Computer Vision Syndrome-Questionnaire
Description
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)
Time Frame
Day 84 before playing videogames on digital device
Secondary Outcome Measure Information:
Title
Asthenopia Visual Fatigue Likert scale
Description
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
Time Frame
Day 0, day 14, day 28, day 56 and day 84.
Title
Immunitythe subject felt sick will be documented in sick diary along with the concomitant medication used (dose and frequency will be captured).
Description
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
Time Frame
Day 14, Day 28, Day 56 and Day 84
Title
Immunity of participan has contracted the common cold/flu
Description
Immunity as assessed by the number of times participant has contracted the common cold/flu during the treatment period, as compared to the placebo.
Time Frame
Day 14, Day 28, Day 56 and Day 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Shalini Srivastava, MD medicine
Organizational Affiliation
Vedic Lifesciences Pvt. Ltd.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aman Hospital and Research Center
City
Ahmedabad
State/Province
Guijarat
ZIP/Postal Code
390021
Country
India
Facility Name
Wavikar Eye Institute
City
Thāne
State/Province
Maharashtra
ZIP/Postal Code
400601
Country
India
Facility Name
Jaipur National University Institute for Medical Sciences & Research Centre
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
To Evaluate the Efficacy and Safety of CAEP-01 on Eye Strain in Children With Heavy Screen Use
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