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

Changes from baseline osmolarity at 28, 56 and 84 days

时间窗: 0 (baseline), 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.

Changes with respect to baseline NIBUT at 28, 56 and 84 days

时间窗: 0 (baseline), 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.

Changes with respect to baseline lipid layer of the tear film at 28, 56 and 84 days

时间窗: 0 (baseline), 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.

Changes with respect to baseline MGD at 28, 56 and 84 days

时间窗: 0 (baseline), 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.

Changes from baseline dry eye symptoms at 28, 56 and 84 days

时间窗: 0 (baseline), 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.

Changes with respect to baseline TMH at 28, 56 and 84 days

时间窗: 0 (baseline), 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.

Changes with respect to baseline ocular surface stainings at 28, 56 and 84 days

时间窗: 0 (baseline), 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.