Effects of AffronEye®/ Crocuvis+® on Dry Eye Syndrome

Dry Eye Syndrome Clinical Trial

Official title:

Effects of AffronEye®/ Crocuvis+® on Dry Eye Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06240364
• Other study ID #: PHARMACTIVE1-24I
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 10, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: University of Alicante
• Contact: María de Mar Seguí Crespo, PhD
• Phone: 00965903400
• Email: svi.az[@]ua.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Previous research has demonstrated the effectiveness of AFFRONEYE® / 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 compare the results of clinical tests that evaluate signs and symptoms for the diagnosis of dry eye, between two groups (some that take the dietary supplement and others a placebo), in a sample of university workers and students who suffer from dry eye.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 204
• Est. completion date: April 30, 2025
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have dry eye according to the diagnostic criteria established by the Tear Film and Ocular Surface Society (TFOS) Dry Eye Workshop (DEWS).

Exclusion Criteria:

• Pathology of the anterior ocular surface under treatment (such as conjunctivitis, keratitis, among others).
• Take any type of dietary supplements, with or without botanical components in the last month.
• Pregnancy or breastfeeding (also excludes recent pregnancy within the last 3 months) and women planning to become pregnant.

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Dietary Supplement:
• Saffron extract (Crocus sativus)
Daily intake of one tablet for 84 days.
• Placebo
Daily intake of one tablet for 84 days.

Locations

Country	Name	City	State
Spain	University of Alicante	San Vicente Del Raspeig	Alicante

Sponsors (2)

Lead Sponsor	Collaborator
University of Alicante	Pharmactive Biotech Products S.L.U

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline dry eye symptoms at 28, 56 and 84 days	Measured with Ocular Surface Disease Index (OSDI, adapted version to spanish). It consists of 12 items that assess symptoms, functional limitations, and environmental factors related to dry eye. The score ranges from 0 to 100 (worst). Each item is evaluated on a 4-point Likert scale (from 0 to 4). The final score is obtained from (the sum of scores for all questions answered x 25) and divide to total number of questions answered (do not included questions answered N/A); dry eye symptoms are considered from = 13 points.	0 (baseline), 28, 56 and 84 days
Primary	Changes with respect to baseline NIBUT at 28, 56 and 84 days	Non-Invasive tear BreakUp Time (NIBUT). It is measured with the Keratograph 5M topographer. It is used to assess tear film stability. It is a non-invasive method to observe and detect the tear film break-up time (measured in seconds). In this case, fluorescein staining can be dispensed with, thus eliminating any influence it may have on the tear film and the results. The region and time course of tear film rupture are automatically measured without user intervention.; The software analyses the Placido projecting rings on the tear film and automatically detects any distortion or discontinuity in the reflected annular pattern. The results are recorded with respect to time and space, and translated into a colour-coded map.; A positive finding has been reported to be a value <10 s.	0 (baseline), 28, 56 and 84 days
Primary	Changes with respect to baseline TMH at 28, 56 and 84 days	Tear Meniscus Height (TMH). It is measured with the Keratograph 5M topographer. It assesses the height of the lacrimal meniscus (measured in millimetres). Firstly, it provides information on the secretory capacity of the main lacrimal gland and secondly, it may indicate a high evaporation rate, which may, for example, be due to an insufficient lipid layer.; It is measured with a ruler from the point of the lower lid margin (below the centre of the pupil) to the upper edge of the lacrimal meniscus.; A positive finding has been reported to be a value <0.2 mm.	0 (baseline), 28, 56 and 84 days
Primary	Changes with respect to baseline ocular surface stainings at 28, 56 and 84 days	Ocular surface stains are used to assess epithelial damage to the cornea, conjunctiva, and lid margin.; To assess corneal epithelial damage, a fluorescein strip is wet with saline, and a drop is instilled inside the lower temporal lid. Optimal viewing is 1-3 minutes after instillation. A positive result is >5 corneal spots.; To assess conjunctival and lid margin damage, a lissamine green strip is wet with saline, and a drop is instilled inside the lower temporal lid. The observation should occur between 1 and 4 min postinstillation.; To assess conjunctival damage, a positive score is > 9 conjunctival spots. To assess lid margin damage, =2 mm in length and/or =25% sagittal width is a positive score.	0 (baseline), 28, 56 and 84 days
Primary	Changes with respect to baseline lipid layer of the tear film at 28, 56 and 84 days	The thickness of the lipid layer is not uniform throughout its structure and is examined by observing an interferential phenomenon with Keratograph 5M topographer.; The ideal pattern is yellow to blue color at around 80-100nm. If excessively colored patterns are observed, this refers to a greater lipid film thickness >100nm. If, on the other hand, the pattern is gray-white, it indicates a thin or absent lipid layer, causing greater evaporation.	0 (baseline), 28, 56 and 84 days
Primary	Changes with respect to baseline MGD at 28, 56 and 84 days	Meibomian Gland Dysfunction (MGD). The morphological changes of these glands are evaluated using the Keratograph 5M topographer using integrated infrared diodes that allow illumination of the everted eyelids.; The Meibomian glands are located in the tarsal conjunctiva of the upper and lower eyelids and have the function of producing an oily substance (meibum), which forms the lipid layer of the tear film, protecting it against evaporation of its aqueous phase.; The number of meibomian glands should be evaluated in the photographs taken; the larger the area without glands, the greater the DGM.	0 (baseline), 28, 56 and 84 days
Primary	Changes from baseline osmolarity at 28, 56 and 84 days	Measured with the Tearlab osmometer. A positive result is considered to be =308 mOsm/L in either eye or an interocular difference >8 mOsm/L.	0 (baseline), 28, 56 and 84 days