Vision DisordersNCT05602402

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

A study testing CAEP-01 in people with Vision Disorders, run by Vedic Lifesciences Pvt. Ltd. at 3 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 10 to 14 years
Conditions the study is for: Vision Disorders
What is being tested?: CAEP-01
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 3 sitesIndia
Study dates: 11 Nov 2022to 24 Apr 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 14 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Show all 9Show fewer

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

Who cannot join

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

Show all 16Show fewer

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.

Trial locations and contacts

3 sites in 1 country.

India3 sites

Aman Hospital and Research Center
Ahmedabad, Guijarat, 390021
Jaipur National University Institute for Medical Sciences & Research Centre
Jaipur, Rajasthan, 302017
Wavikar Eye Institute
Thane, Maharashtra, 400601

Other trials in India

About this study

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.

Conditions: Vision Disorders
Being tested: CAEP-01, Placebo
Medical subject headings: Vision Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CAEP-01Other
Dose: 1 capsule Route: orally for 84 ± 3 days Regimen: one capsule before breakfast (preferably with milk/butter/ghee)
PlaceboOther
Dose: 1 capsule Route: orally for 84 ± 3 days Regimen: one capsule before breakfast (preferably with milk/butter/ghee)

Study groups in NCT05602402
Study group	Role	What they receive
CAEP-01	Active comparator	Dose: 1 capsule Route: orally for 84 ± 3 days Regimen: one capsule beforebreakfast (preferably with milk/butter/ghee) Receives: Other: CAEP-01
Placebo	Placebo comparator	Dose: 1 capsule Route: orally for 84 ± 3 Regimen: one capsule before breakfast (preferably with milk/butter/ghee) Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Day 84 before playing videogames on digital device

Secondary outcomes (3)

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
Measured: 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
Measured: 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.
Measured: Day 14, Day 28, Day 56 and Day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Nov 202224 Apr 2023

First posted2 Nov 2022
Study start11 Nov 2022
Primary completion24 Apr 2023
Study completion24 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Vision DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Participant, Investigator
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05602402
Sponsor's protocol ID: AP/220201/CAEP/ES
Status last verified: Apr 2023
First submitted: 17 Oct 2022
Last updated: 27 Apr 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Hecht KA, Marwah M, Wood V, Nishida Y, Bach AE, Gerson J, Hom MM, Schnackenberg J, Raote S, Srivastava S, Negi P, Caston E. Astaxanthin (AstaReal(R)) Improved Acute and Chronic Digital Eye Strain in Children: A Randomized Double-Blind Placebo-Controlled Trial. Adv Ther. 2025 Apr;42(4):1811-1833. doi: 10.1007/s12325-025-03125-7. Epub 2025 Feb 27.
PubMed 40014233

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: To Evaluate the Efficacy and Safety of CAEP-01 on Eye Strain in Children With Heavy Screen Use
ClinicalTrials.gov ID: NCT05602402
Acronym / sponsor ID: AP/220201/CAEP/ES
Conditions: Vision Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
Study start: 11 Nov 2022 (actual)
Primary completion: 24 Apr 2023 (actual)
Study completion: 24 Apr 2023 (actual)
First posted: 2 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
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)

Arm	Type	Receives
CAEP-01	Active comparator	Other: CAEP-01Dose: 1 capsule Route: orally for 84 ± 3 days Regimen: one capsule beforebreakfast (preferably with milk/butter/ghee)
Placebo	Placebo comparator	Other: PlaceboDose: 1 capsule Route: orally for 84 ± 3 Regimen: one capsule before breakfast (preferably with milk/butter/ghee)

Who may qualify

Ages: 10 to 14 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CAEP-01Dose: 1 capsule Route: orally for 84 ± 3 days Regimen: one capsule before breakfast (preferably with milk/butter/ghee)	Other	CAEP-01
PlaceboDose: 1 capsule Route: orally for 84 ± 3 days Regimen: one capsule before breakfast (preferably with milk/butter/ghee)	Other	Placebo

Primary outcome

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)
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)
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)
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)
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)
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)

3 secondary outcomes

Asthenopia Visual Fatigue Likert scale
Time frame: 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).
Time frame: Day 14, Day 28, Day 56 and Day 84
Immunity of participan has contracted the common cold/flu
Time frame: Day 14, Day 28, Day 56 and Day 84

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
Derived from this study: PubMed 40014233Hecht KA, Marwah M, Wood V, Nishida Y, Bach AE, Gerson J, Hom MM, Schnackenberg J, Raote S, Srivastava S, Negi P, Caston E. Astaxanthin (AstaReal(R)) Improved Acute and Chronic Digital Eye Strain in Children: A Randomized Double-Blind Placebo-Controlled Trial. Adv Ther. 2025 Apr;42(4):1811-1833. doi: 10.1007/s12325-025-03125-7. Epub 2025 Feb 27.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dr Shalini Srivastava, MD medicine principal investigator

Vedic Lifesciences Pvt. Ltd.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CAEP-01 in people with Vision Disorders, run by Vedic Lifesciences Pvt. Ltd. at 3 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Computer Vision Syndrome-Questionnaire (time frame: Screening before playing videogames on digital device). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05602402, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.