Computer Vision SyndromeNCT05211063
Effects of CROCUVIS+® on Computer Vision Syndrome, Sleep and Mood Disorders
A study testing Saffron extract (Crocus sativus) in people with Computer Vision Syndrome and Sleep Disorder, run by University of Alicante at 1 site in Spain.
Trial summary
Previous research has shown the efficacy of CROCUVIS+® dietary supplement, based on saffron extract, in the proper functioning of visual health, for example, against the development of glaucoma. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Computer Vision Syndrome, Sleep Disorder, Mood Disorders
- What is being tested?
- Saffron extract (Crocus sativus)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 21 Oct 2022to 5 May 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- CVS-Q© score ≥6.
- Age between 18 and 40 years (both inclusive).
- Exposure to digital devices 4 hours a day, at least five days a week or more and maintain the same level of exposure throughout the study period.
Who cannot join
- Monocular corrected distance visual acuity >0.0 LogMAR.
- Ocular pathology under treatment at the time of the study.
- Previous ocular surgery that could affect the tear film or the ocular surface.
- Ocular Surface Disease Index (OSDI) questionnaire score ≥13.
- Previous diagnosis or history of dry eye syndrome and/or blepharitis.
- Regular (daily) use of rigid or soft contact lenses ≥3 days a week.
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- Regular use of any ocular lubricant.
- History of oral intake of dietary supplements, with or without herbal ingredients, intended to contribute, maintain or reduce the risk of suffering diseases related to visual function, mood or sleep within the four weeks before the study enrollment.
- Systemic disease:
- Uncontrolled hypertension (systolic/diastolic blood pressure >140/90 mmHg).
- Uncontrolled diabetes mellitus (fasting blood glucose level >180 mg/dL).
- Rheumatoid arthritis.
- Tumor disease.
- Active hepatitis (type B and C).
- Active infectious disease.
- Kidney disease that compromises diuresis.
- Current systemic treatment or in the last 3 months with drugs that may interfere with the results, for example:
- Opioids.
- Antipsychotics.
- Antibiotics (tetracyclines, sulfonamides)
- Antiarthritic drugs (hydroxychloroquine)
- Hypotensive drugs (beta-blockers)
- Anticoagulants (heparin, warfarin, or clopidogrel)
- Antidepressants (such as fluoxetine, among others)
- Hypnotics (eg, benzodiazepines)
- Habitual smoker and/or alcohol drinker. More than 3 cigarettes per day and/or more than 3 Standard Drink Units (SDU) per week, including weekends. SDU is defined as the consumption of 10 ml of alcohol.
- Regular job with rotating shifts including night shift in the last month (including weekends).
- Pregnancy or breastfeeding (also excludes recent pregnancy within the last 3 months) and women planning to become pregnant.
- Participation in another clinical trial in the last 3 months.
- Take any type of dietary supplements with botanical components in the last month.
Trial locations and contacts
1 site in 1 country.
About this study
Previous research has shown the efficacy of CROCUVIS+® dietary supplement, based on saffron extract, in the proper functioning of visual health, for example, against the development of glaucoma. The main objective of this study is to evaluate the efficacy of CROCUVIS® in computer vision syndrome, sleep and mood disorders in a sample of university students who use digital devices.
- Conditions
- Computer Vision Syndrome, Sleep Disorder, Mood Disorders
- Being tested
- Saffron extract (Crocus sativus), Placebo
- Medical subject headings
- Sleep Wake Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saffron extract (Crocus sativus)Dietary supplement
Daily intake of one tablet for 42 days.
PlaceboDietary supplement
Daily intake of one tablet for 42 days.
| Study group | Role | What they receive |
|---|---|---|
| Saffron extract (Crocus sativus) | Experimental | Daily intake of one tablet for 42 days. Receives: Dietary Supplement: Saffron extract (Crocus sativus) |
| Placebo | Placebo comparator | Daily intake of one tablet for 42 days. This tablet is organoleptically indistinguishable from the experimental tablet. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline computer vision syndrome at 14, 28 and 42 days
Measured with the Computer Vision Syndrome Questionnaire (CVS-Q©). It evaluates the frequency and intensity with which 16 symptoms are perceived over the time of use of digital devices. The score ranges from 0 to 32; computer vision syndrome is considered ≥6. The higher score a subject gained, the worsen ocular condition he/she experienced.
Measured: 0 (baseline), 14, 28 and 42 days
Change from baseline sleep disorders at 14, 28 and 42 days
Measured with the Insomnia Severity Index (ISI). It evaluates 7 items. The score ranges from 0 to 28 (worst). Each item is evaluated on a 5-point Likert scale (from 0 to 4). The final score is obtained from the sum of the responses of all items; insomnia is considered ≥8.
Measured: 0 (baseline), 14, 28 and 42 days
Change from baseline mood at 14, 28 and 42 days
Measured with the Profile of Mood States (POMS). It evaluates 58 items that form 6 factors (tension, depression, anger, vigour, fatigue, and confusion). The score ranges from 68 to 300 (worst mood). Each item is evaluated with a 5-point Likert scale (from 0 to 4). The score of each factor is obtained from the sum of the responses of all the items that define it.
Total Mood Disturbance = 100+ (Tension + Depression + Anger + Fatigue + Confusion) - Vigour
Measured: 0 (baseline), 14, 28 and 42 days
Secondary outcomes (2)
Change from baseline quality of life related to health at 42 days
Measured with Short Form-36 survey (SF-36). It evaluates 36 items that form 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health). The scores are weighted sums of the questions in each section. The score ranges from 0 to 100. Lower scores = more disability, higher scores = less disability.
Measured: 0 (baseline) and 42 days
Satisfaction question
A single satisfaction question. Participants must respond by selecting a number from a Likert scale from 0 to 5.
Measured: Last visit (42 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start21 Oct 2022
- Primary completion27 Dec 2022
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Computer Vision SyndromeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alicante
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmactive Biotech Products S.L.U
- Responsible party
- Principal investigator, Maria del Mar Seguí Crespo, University of Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211063
- Sponsor's protocol ID
- PHARMACTIVE-21TPA
- Status last verified
- May 2023
- First submitted
- 10 Dec 2021
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of CROCUVIS+® on Computer Vision Syndrome, Sleep and Mood Disorders
- ClinicalTrials.gov ID
- NCT05211063
- Acronym / sponsor ID
- PHARMACTIVE-21TPA
- Conditions
- Computer Vision Syndrome, Sleep Disorder, Mood Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of AlicanteUniversity, hospital or other
- Collaborators
- Pharmactive Biotech Products S.L.U
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 27 Dec 2022 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 27 Jan 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.
Previous research has shown the efficacy of CROCUVIS+® dietary supplement, based on saffron extract, in the proper functioning of visual health, for example, against the development of glaucoma. The main objective of this study is to evaluate the efficacy of CROCUVIS® in computer vision syndrome, sleep and mood disorders in a sample of university students who use digital devices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saffron extract (Crocus sativus) | Experimental | Dietary Supplement: Saffron extract (Crocus sativus)Daily intake of one tablet for 42 days. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDaily intake of one tablet for 42 days. This tablet is organoleptically indistinguishable from the experimental tablet. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- CVS-Q© score ≥6.
- Age between 18 and 40 years (both inclusive).
- Exposure to digital devices 4 hours a day, at least five days a week or more and maintain the same level of exposure throughout the study period.
Key exclusion criteria (30 listed)
- Monocular corrected distance visual acuity >0.0 LogMAR.
- Ocular pathology under treatment at the time of the study.
- Previous ocular surgery that could affect the tear film or the ocular surface.
- Ocular Surface Disease Index (OSDI) questionnaire score ≥13.
- Previous diagnosis or history of dry eye syndrome and/or blepharitis.
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 |
|---|---|---|
| Saffron extract (Crocus sativus)Daily intake of one tablet for 42 days. | Dietary supplement | Saffron extract (Crocus sativus) |
| PlaceboDaily intake of one tablet for 42 days. | Dietary supplement | Placebo |
Primary outcome
Change from baseline computer vision syndrome at 14, 28 and 42 days
Time frame: 0 (baseline), 14, 28 and 42 days
Measured with the Computer Vision Syndrome Questionnaire (CVS-Q©). It evaluates the frequency and intensity with which 16 symptoms are perceived over the time of use of digital devices. The score ranges from 0 to 32; computer vision syndrome is considered ≥6. The higher score a subject gained, the worsen ocular condition he/she experienced.
Change from baseline sleep disorders at 14, 28 and 42 days
Time frame: 0 (baseline), 14, 28 and 42 days
Measured with the Insomnia Severity Index (ISI). It evaluates 7 items. The score ranges from 0 to 28 (worst). Each item is evaluated on a 5-point Likert scale (from 0 to 4). The final score is obtained from the sum of the responses of all items; insomnia is considered ≥8.
Change from baseline mood at 14, 28 and 42 days
Time frame: 0 (baseline), 14, 28 and 42 days
Measured with the Profile of Mood States (POMS). It evaluates 58 items that form 6 factors (tension, depression, anger, vigour, fatigue, and confusion). The score ranges from 68 to 300 (worst mood). Each item is evaluated with a 5-point Likert scale (from 0 to 4). The score of each factor is obtained from the sum of the responses of all the items that define it. Total Mood Disturbance = 100+ (Tension + Depression + Anger + Fatigue + Confusion) - Vigour
2 secondary outcomes
Change from baseline quality of life related to health at 42 days
Time frame: 0 (baseline) and 42 days
Satisfaction question
Time frame: Last visit (42 day)
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 11 May 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saffron extract (Crocus sativus) in people with Computer Vision Syndrome and Sleep Disorder, run by University of Alicante at 1 site in Spain.
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 3 inclusion and 30 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 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Change from baseline computer vision syndrome at 14, 28 and 42 days (time frame: 0 (baseline), 14, 28 and 42 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2023.