Clinical trial NCT05211063: 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
Overall status: COMPLETED
Phase: NA
Conditions: Computer Vision Syndrome
Sleep Disorder
Mood Disorders
Lead sponsor: University of Alicante
Sponsor class: OTHER
Collaborators: name: Pharmactive Biotech Products S.L.U
First posted: 2022-01-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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:

  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.

Primary outcomes:
measure: Change from baseline computer vision syndrome at 14, 28 and 42 days
timeFrame: 0 (baseline), 14, 28 and 42 days
measure: Change from baseline sleep disorders at 14, 28 and 42 days
timeFrame: 0 (baseline), 14, 28 and 42 days
measure: Change from baseline mood at 14, 28 and 42 days
timeFrame: 0 (baseline), 14, 28 and 42 days
Secondary outcomes:
measure: Change from baseline quality of life related to health at 42 days
timeFrame: 0 (baseline) and 42 days
measure: Satisfaction question
timeFrame: Last visit (42 day)
Other outcomes:
Locations:
city: San Vicente Del Raspeig
country: Spain
facility: University of Alicante
state: Alicante
Study officials:
References: