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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
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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