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Effects of CROCUVIS+® on Computer Vision Syndrome, Sleep and Mood Disorders

Primary Purpose

Computer Vision Syndrome, Sleep Disorder, Mood Disorders

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Saffron extract (Crocus sativus)
Placebo
Sponsored by
University of Alicante
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Computer Vision Syndrome

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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:

    1. Uncontrolled hypertension (systolic/diastolic blood pressure >140/90 mmHg).
    2. Uncontrolled diabetes mellitus (fasting blood glucose level >180 mg/dL).
    3. Rheumatoid arthritis.
    4. Tumor disease.
    5. Active hepatitis (type B and C).
    6. Active infectious disease.
    7. Kidney disease that compromises diuresis.

  • Current systemic treatment or in the last 3 months with drugs that may interfere with the results, for example:

    1. Opioids.
    2. Antipsychotics.
    3. Antibiotics (tetracyclines, sulfonamides)
    4. Antiarthritic drugs (hydroxychloroquine)
    5. Hypotensive drugs (beta-blockers)
    6. Anticoagulants (heparin, warfarin, or clopidogrel)
    7. Antidepressants (such as fluoxetine, among others)
    8. 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.

Sites / Locations

  • University of Alicante

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Saffron extract (Crocus sativus)

Placebo

Arm Description

Daily intake of one tablet for 42 days.

Daily intake of one tablet for 42 days. This tablet is organoleptically indistinguishable from the experimental tablet.

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

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.
Satisfaction question
A single satisfaction question. Participants must respond by selecting a number from a Likert scale from 0 to 5.

Full Information

First Posted
December 10, 2021
Last Updated
May 10, 2023
Sponsor
University of Alicante
Collaborators
Pharmactive Biotech Products S.L.U
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1. Study Identification

Unique Protocol Identification Number
NCT05211063
Brief Title
Effects of CROCUVIS+® on Computer Vision Syndrome, Sleep and Mood Disorders
Official Title
Effects of CROCUVIS+® on Computer Vision Syndrome, Sleep and Mood Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 21, 2022 (Actual)
Primary Completion Date
December 27, 2022 (Actual)
Study Completion Date
May 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alicante
Collaborators
Pharmactive Biotech Products S.L.U

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Computer Vision Syndrome, Sleep Disorder, Mood Disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saffron extract (Crocus sativus)
Arm Type
Experimental
Arm Description
Daily intake of one tablet for 42 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily intake of one tablet for 42 days. This tablet is organoleptically indistinguishable from the experimental tablet.
Intervention Type
Dietary Supplement
Intervention Name(s)
Saffron extract (Crocus sativus)
Intervention Description
Daily intake of one tablet for 42 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Daily intake of one tablet for 42 days.
Primary Outcome Measure Information:
Title
Change from baseline computer vision syndrome at 14, 28 and 42 days
Description
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.
Time Frame
0 (baseline), 14, 28 and 42 days
Title
Change from baseline sleep disorders at 14, 28 and 42 days
Description
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.
Time Frame
0 (baseline), 14, 28 and 42 days
Title
Change from baseline mood at 14, 28 and 42 days
Description
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
Time Frame
0 (baseline), 14, 28 and 42 days
Secondary Outcome Measure Information:
Title
Change from baseline quality of life related to health at 42 days
Description
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.
Time Frame
0 (baseline) and 42 days
Title
Satisfaction question
Description
A single satisfaction question. Participants must respond by selecting a number from a Likert scale from 0 to 5.
Time Frame
Last visit (42 day)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Facility Information:
Facility Name
University of Alicante
City
San Vicente Del Raspeig
State/Province
Alicante
ZIP/Postal Code
03690
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of CROCUVIS+® on Computer Vision Syndrome, Sleep and Mood Disorders

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