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lacr if r es h 0,20% 0,30% Ocular Dryness DRY EYE SYNDROME Dry eye syndrome (DES) is a highly prevalent inflammatory disorder that affects millions of people worldwide, being one of the main reasons for visiting an ophthalmologist. It has been found that 64% of patients who visit an optometrist in the US have symptoms of ocular discomfort. Moreover, a study in Canada found that 28.7% of patients attending an optometric practice showed symptoms of DES. A large epidemiological study found a prevalence of DES in people over 55 years old. DES can be classified into two types: one based on origin and the other on severity. When based on origin, it is divided into two types: ONE DUE TO DEFICIENT TEAR PRODUCTION: this is due to inadequate tear production from lachrymal hyposecretion. THE OTHER DUE TO EXCESSIVE TEAR EVAPORATION: this is due to excessive loss of fluids from the exposed ocular surface, even with normal tear secretory function. When based on severity, it can be classified into 4 levels: 1. Slight 2. Moderate 3. Severe 4. Very severe As for the root causes of eye dryness, several risk factors have been found: - Low-humidity environments: unventilated, air-conditioned offices environments, environments with smoke and extremely low-humidity environments such as aircraft cabins. -C omputer use: often computer users complain of eye strain, a burning or gritty sensation in the eyes, etc. - Contact lens use: 50-75% of contact lens wearers report symptoms of ocular irritation. -R efractive surgery: after LASIK (laser-assisted in situ keratomileusis) surgery, a decrease in tear secretion occurs. The prevalence of DES in patients who have undergone LASIK surgery seems greater in the immediate postoperative period. -S ex hormones: androgen levels decrease with age in both men and women. Sex steroid deficiency, especially that involving androgens, has been associated with DES. One of the treatments available to relieve DES symptoms involves the use of eye lubricating solutions. These are available on the market, including solutions that contain sodium hyaluronate. lacrifresh l a c r i f re s h 0,20% 0,30% Both formulas contain salts that are found in the human eye: Sodium chloride Magnesium chloride Potassium chloride Calcium chloride People who suffer from either slight to moderate or moderate to serious dry eyes: •H ave a tear with more concentration of salts due to more evaporation and less tear replacement. • With an enhanced tonicity: hypertonic tears. •N eed hypotonic eye drops in order to correct this imbalance. The human tears “latch onto” the water in the eye drops, enabling them to become isotonic/balanced. The drier the eyes, the more hypotonic the eye drops need to be in order to treat them. The greater the concentration of sodium hyaluronate, the greater the viscosity and therefore the longer the presence on the artificial drop and therefore, the longer the lubricating effect on the eye. The addition of the glycerine strengthens and enhances lubrication, joining the action of sodium hyaluronate. SODIUM HYALURONATE GLYCERINE + ++ + = + == == HYPERTONIC DRY EYE HYPOTONIC OCU DRY 0,20% ISOTONIC HEALTHY TEAR 0,30% These eye drops have a lower concentration of sodium chloride than the rest of Avizor eye drops and as such a lower tonicity. They are therefore hypotonic. These eye drops have a even lower concentration of sodium chloride than Lacrifresh ocu-dry 0.2% and as such have a much lower tonicity; it is the most hypotonic of the two products. They are designed for people who suffer from slight or moderate dry eyes on an occasional basis and act to alleviate their symptoms. They are designed for people who suffer from moderate or serious dry eyes and provide prolonged relief of their symptoms. Aqueous, buffered and hypotonic solution with sodium hyaluronate 0.20%, glycerine and essential electrolytes (Cl-, Na+, Ca2+, K+, Mg2+). Aqueous, buffered and hypotonic solution with sodium hyaluronate 0.30%, glycerine and essential electrolytes (Cl-, Na+, Ca2+, K+, Mg2+).(Cl-, Na+, Ca2+, K+, Mg2+). Viscosity 17-20 cP Viscosity 50-52 cP Definitions OCULAR SURFACE DISEASE INDEX (OSDI) TEST (0-100 points) The 12 questions related to subjective symptoms of discomfort/distress were defined as follows: • • • • • 4 Always 3 Almost always 2 Half the time 1 Occasionally 0 Never The primary effectiveness variable was defined as the proportion of subjects displaying a reduction in symptoms by at least 5 points according to the OSDI test at the end of the month. USER SATISFACTION (0-10 points) The patient provided a vertical-line score of their level of satisfaction with the eye lubricating solution at the time of testing. OCULAR SURFACE STAINING Assessment of epithelial damage on ocular surface was carried out through corneal fluorescein staining. TEAR FILM STABILITY THROUGH BUT MEASUREMENT (in seconds) 5 μl of sodium fluorescein (2%) was instilled with a pipette into the lower conjunctival sac and the subject was asked to blink several times so that the fluorescein would spread over the ocular surface. They were then asked to stop blinking and we examined the surface of the cornea using a slit lamp. The time interval between the last blink and the appearance of the first black spot or discontinuity of staining with fluorescein on the tear film was recorded in seconds. Three measurements were taken, considering the BUT as the average of the three measurements. SCHIRMER’S TEST (in millimetres) A Schirmer’s Test was performed without topical anaesthetic. A Schirmer’s Test strip was placed on the outer edge of the eyelid margin. The patient remained with their eyes closed for 5 minutes, after which the strip was removed. The section of the strip that had been moistened with tears was measured and scored in millimetres. The Clinical Study The study included a total of 32 subjects (16 per study arm) over 18 years old with symptoms of ocular dryness according to the Ocular Surface Disease Index (OSDI) test and classed as non-contact lens wearers at the time the study was performed. Symptoms according to the OSDI test: • Group 1 (mild eye dryness): between 13 and 22 points. • Group 2 (moderate to severe eye dryness): more than 22 points. Patients had to have at least 2 of the following altered tests: • BUT ≤ 10 seconds. • Corneal Fluorescein Staining ≥ 1. • Conjunctival Staining with lissamine green ≥ 1. • Schirmer’s Test ≤ 5 mm without aesthetic. Two groups (16 and 16) were created in order to evaluate their individual composition from 0.2% and 0.3% separately. During the first 7 days, the patients underwent cleaning with saline solution. Subsequently, the clinical study began, consisting of checks every 15 days. Throughout the study, the symptoms of ocular dryness were assessed and compared through: • OSDI Test results. • Assessment and comparison of user satisfaction through a visual rating scale from 0 to 10. • Assessment and comparison of ocular surface staining presence. • Assessment and comparison of tear film stability through BUT measurement. •A ssessment and comparison of lachrymal production by using Schirmer’s test measurements. lacrifresh resultS 0,20% OSDI (patients between 13 and 22): Valor medio de OSDI en cada Visita Control The patients’ average scores in the OSDI test went from 17.95 to 14.42 throughout the month of the study. 20 17,95 15,64 15 Average Score of OSDI each every check visit 14,42 10 5 0 1 2 3 Reducción de la sintomatología en, al menos, 5 puntos Throughout this month, an increase was observed over time in the number of patients 6 whose OSDI values decreased. That is to say, the more time went by, the larger the number Reducción de la sintomatología of patients whose OSDI values decreased. 5 en, al menos, 5 puntos 4 6 3 5 2 4 Reduction of symptoms 1 in at least 5 pts 0 3 0 days 2 1 month 15 days 1 Patients 0 Tendence 0 days 15 days 1 month Satisfacción en el Uso del producto Patients USER SATISFACTION: Tendence A significant8 increase in the level of user satisfaction by the subjects after using Visaid 0.2% Satisfacción en el scores Uso del going producto 7 was observed, the Satisfacción average users’ from 5.47 to 6.71. en el Uso del producto 6,71 6 5,47 5 8 8 4 7 3 6 2 5 7 5,47 5,47 5 4 4 1 User Satisfation 0 3 3 1 2 3 2 1 0 6,71 6,71 6 2 1 Level of satisfaction 1 2 Level of satisfaction 0 3 1 2 Level of satisfaction 3 Tinción Corneal CORNEAL STAINING: Over the month where LACRIFRESH OCU-DRY 0.2% was used, control checks showed an 1,4 increasing number of patients obtaining lower values. The average went from 1.12 in the first 1,2 Tinción Corneal visit to 0.31 in the third visit. 1 0,8 1,4 0,6 1,2 0,4 1 0,2 0,8 0 0,6 3 Corneal Staining 1 2 0,4 Corneal staining Tendence 0,2 0 1 2 3 Corneal staining Tendence It may be stated that one month after treatment, a significant decrease in corneal staining intensity occurred when Visaid 0.2% had been used. BUT: An increase of nearly 6% in tear breakup time was detected and improved tear stability was thus observed. SCHIRMER’S TEST: An increase of just over 9% in tear volume results was observed. Subjects with mild eye dryness who used Visaid 0.2% for one month saw their symptoms improve significantly, as did their level of user satisfaction, intensity of corneal fluorescein staining and bulbar hyperaemia. After a month of use Visaid 0.3%, subjects with moderate to severe eye dryness showed a significant reduction in symptoms and a significant increase in tear stability (BUT) when Visaid 0.3% had been used. lac r ifresh results 0,30% OSDI (patients over 22): Valor medio de OSDI en cada Visita Control The patients’ average scores in the OSDI test went from 51.11 to 46.61 throughout the month of the study. 52 51,11 51 50 Average OSDI values in each check visit 49 48,42 48 Reducción de la sintomatología en, al menos, 5 puntos 47 46,61 46 45 9 44 8 1 2 3 7 Throughout this month, an increase in the number of patients whose OSDI values decreased over 6 Reducción la sintomatología time was observed. That is to say, the more time went by, the largerde the number of patients 5 en, al menos, 5 puntos whose OSDI values decreased. 4 9 3 8 2 7 1 Symptom reduction by at least 5 points 0 6 5 0 days 15 days 1 month Tinción Corneal 4 3 Patients 2 1 Tendence 3 0 0 days 15 days 1 month 2,5 CORNEAL STAINING: Patients Over the month where Visaid 0.3% was used, control checks showed an increasing number of 2 TendenceTinción Corneal patients obtaining lower values. The average went from 2.56 in the first visit to 1.75 in the third visit. 1,5 3 1 2,5 0,5 Corneal Staining 0 2 1 2 3 1,5 1 Corneal staining Tendence 0,5 0 1 2 3 It may be stated that one month after treatment, a significantCorneal decrease in corneal staining staining intensity occurred when Visaid 0.3% had been used. Tendence BUT: An increase of nearly 14% in tear breakup time was detected and improved tear stability was thus observed. SCHIRMER’S TEST: An increase of just over 16.67 in tear volume results was detected. la c r i f r esh 0,20% 0,30% PRESER VAT I V E FREE Viscosity 17-20 cP SODIUM HYALURONATE GLYCERINE Viscosity 50-52 cP Designed for anyone who suffers from dry eyes. Only in single-dose format. Preservative free. These lubricating eye drops are designed to alleviate the symptoms of dry eyes. Avenida de La Innovación, 2, Parque Leganés Tecnológico, 28919 Leganés Madrid Spain T. +34 916 564 803 F. +34 916 762 757 E. [email protected] www.avizor.com