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Rohto dry eye relief
Results of a UK multi-centre, field-based, post-marketing study
Nick Atkins looks at a study of practitioner and patient use of a new dry eye preparation
R
ohto Dry Eye Relief
(Figure 1) is a new
alternative for the
managementofdryeyes,
manufactured by The
MentholatumCompany.
Rohto Dry Eye Relief (RDER)
is a novel solution that contains a
patented bi-polymer. Trade named
HydraMed, this bi-polymer is formed
fromthecooperativeinteractionoftwo
naturally occurring polysaccharides,
hyaluronic acid (HA), and tamarind
seed polysaccharide (TSP).1 The latter
is a new polysaccharide to the UK, with
muco-mimeticpropertiesandisderived
from the seed of the Tamarind tree.
Table 1 shows the solution is available
in multi-dose and, what the company
describes as, a daily-dose unit (DDU).
The DDU has a novel replaceable cap
with data supporting the safety of its
reuse within 12 hours.
Study format and protocol
During the winter of 2009-10,
10UK-basedpractitionersparticipated
inapractice-basedstudytoevaluatethe
performance of RDER dry eye drops.
This was not a true clinical trial; more
a real-worldevaluationby bothpatient
andpractitioner,wherethepractitioner
was free to select which patients were
dispensed,albeitwithintheacceptance
criteria of the study. The purpose of
the study was to gather simple data
supporting the efficacy and patient
acceptance of the product.
Practitioner
and
patient
questionnaires were used to gather
data on the eye drop’s performance.
Apart from the obligatory discrete
data, for ease of completion by both
patientandpractitioner,theformswere
largely made up of statements that the
completer simply had to rate their level
of agreement or disagreement with on
a five-point Linkert scale.
Each practitioner was asked to enter
three or more patients into this study.
Eachsubjectwasexaminedattheinitial
visit to determine eligibility. A patient
was deemed eligible if they had one or
moresymptom(suchasoculardryness,
grittiness or redness) or sign (such as a
low TBUT) of a mild to moderate dry
eye. Diagnosis of severe dry eye and
28 | Optician | 21.05.10
Figure 1
Table 1
Format
Size
Preservative
Expiry
Shelf life
Daily dose unit
20 x 0.5ml
5 x 0.5ml
None
12 hours
3 years
10ml bottle
10ml
BAK 0.1%
28 days
3 years
contact lens wear were the primary
exclusion criteria.
The investigating practitioners were
randomly assigned either a 10ml multidosebottleorthe0.5mlDDUofthedrop
toevaluate,withtherecommendationfor
thepatienttousethedrop2-3timesaday.
Only one follow-up visit was required
and this was scheduled at an interval
of 2-4 weeks after initial dispensing.
Classification of clinical findings
followed the Efron Grading Scale, but
on a simpler 1-4 whole number scale.
Twodocuments,thePractitionerReport
Form and the Patient Questionnaire,
had to be completed at both the initial
(dispensing) and the follow-up visit.
Overview
Ten practices participated, supplying
completedpaperworkforthedispensing
of RDER to a total of 39 patients.
All multi-dose patients returned for
follow-up with four DDU patients
not returning, meaning follow-up
data was submitted for 35 patients (70
eyes).Twenty-eight (82 per cent) of the
patientsseenatdispensingwerefemale
and 11 (18 per cent) were male. The
mean age of the study participants was
61.2 years with the youngest recorded
being 20 and the oldest 84.
Sixty-nine per cent of the patients
entered into the study had previously
used dry eye drops, with 61 per cent
having used a multi-dose product
and 39 per cent a unit-dose format.
All patients who had previously used
drops felt those drops provided some
kind of relief; 56 per cent of patients
answered ‘Yes’ to the question ‘Does
using drops relieve your symptoms?’
with46percentstatingtheysometimes
provided symptom relief. The type of
drop was recorded for 17 patients and
the variety of drops used immediately
prior to dispensing RDER, as well as
their prevalence can be seen in Figure 2
(notethatsomepatientsusedmorethan
one type of drop).
General performance
Initial comfort
Patients were asked to report any
irritation they felt upon instillation
of RDER. All patients reported that
they had no discomfort upon drop
instillation.
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Clinical
Symptoms
There were a range of dry eye related
symptomsreportedbypatientsatboth
dispensing and follow-up. Figure 3
shows the incidence of symptoms
reportedatboththedispensingandthe
follow-up appointment. At dispensing
dryness,grittinessanditchysymptoms
were most prevalent. There was a
much lower reported incidence of
all symptoms at the follow-up visit
with more than a four-fold reduction
in dryness symptoms. Twenty-five
patients(64percent)reporteddryness,
amongothersymptoms,atdispensing.
At the follow-up visit, having used
RDER, only six patients (15 per cent)
reported this symptom.
Figure 4 shows how the patient
symptoms at the end of the day
comparedwithpre-study.Thequestion
wasaskedatthreedifferenttimepoints
with the addition of early and middle
of the day, and the majority of patients
(ranging from 73 per cent to 83 per
cent)reportedRDERasbetterthantheir
pre-study situation. Only one patient,
and only at the end of day time point,
stated their eyes felt worse.
Ocular comfort scores (OCS)
Patients were asked to ring the
(whole) number that they felt best
represented their ocular comfort on a
visual analogue scale of 1-10, where 1
= extremely uncomfortable and 10 =
completely comfortable. There was a
mean improvement in ocular comfort
scoreof2.8withthemeancomfortscore
at dispensing being 5.4, improving to
8.2 following use of RDER. 91 per cent
of users (32) rated their OCS with this
drop as 7 or over.
Practitioner data
Clinical signs
The investigating practitioners were
asked to record the clinical grading
levels of four clinical signs, namely
cornealstaining,conjunctivalstaining,
conjunctivalrednessandlimbalredness,
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atbothdispensingandfollow-up.Most
patients presented with either mild or
none of these clinical signs. Overall
there were no differences likely to
be of clinical significance between
the grading levels at dispensing or
follow-up visits.
The investigators recorded their
agreement with a series of statements
for every patient followed up after using
RDER. The practitioner opinions for
sevenstatementsforthe35patientswho
completedthestudycanbeseenbelow.
1 RDER performed better than the
patient’s previous drop
Fifty-six per cent of investigator
individual (patient) responses either
strongly agreed or agreed with this
statement. Thirty-three per cent
either strongly disagreed (7 per cent)
or disagreed (26 per cent) with this
statement
2 RDER performed as well as I would
have liked
Forty-three per cent of investigator
individual (patient) responses either
strongly agreed or agreed with this
statement. Forty per cent of responses
either strongly disagreed (9 per cent)
or disagreed (31 per cent) with this
statement
3 Patient relief with RDER was better
than I expected
For this statement the most prevalent
response was neutral at 43 per cent.
Twenty-eight per cent of investigator
individual (patient) responses agreed
with this statement (none strongly
agreed). Thirty-nine per cent of
responses either strongly disagreed (3
percent)ordisagreed(36percent)with
this statement
4 The use of a preservative didn’t seem
to affect the performance of the drop
Inthepreservedmulti-dosebottlegroup,
90 per cent of investigator individual
(patient)responses(includingthosewho
were neutral) felt that the preservative
didn’tnegativelyaffecttheperformance
of the drop
5 The patient complied with the daily
disposal of the daily dose vial. In the
DDU group 73 per cent of investigator
individual (patient) responses to this
statement either strongly agreed or
agreed. There was no disagreement to
this statement
6 A re-sealable daily dose vial is an
effective method of delivering a
preservative free eye drop
In the DDU group 80 per cent of
investigators individual (patient)
responses to this statement either
strongly agreed or agreed. Seven per
cent disagreed and 13 per cent were
neutral to this statement
7 I will recommend this patient
continues to use RDER
Seventy-fourpercentoftheinvestigator
individual (patient) responses stated
thattheywouldrecommendthepatient
continued to use the new drop. One
patient(3percent)remainedusingtheir
previous drop (Figure 5).
Patient data
Both groups of patients felt RDER
provided some kind of relief; 75 per
cent of patients answered ‘Yes’ to the
question‘Doesusingdropsrelieveyour
symptoms?’comparedwith56percent
ofusersofotherdropspre-participation
in the study. 25 per cent stated that
the study drop sometimes provided
symptom relief. In addition to ocular
21.05.10 | Optician | 29
Clinical
comfort scores patients were asked
whether RDER improved their eye
comfort; 75 per cent of patients
answered a definitive ‘Yes’ with no
patients answering ‘No’.
Figure 6 shows the responses to the
question ‘What levels of relief did RDER
generallyprovideyourdryeyesensations
during the day?’ Patients could provide
multiple answers to this question and it
can be seen that all respondents felt that
RDER provided relief, with six times
more responses (12 vs 2 and 33 per cent
ofallresponses)statingthatthenewdrop
provided long-term relief.
Following on from the previous
question about the level of relief, an
analysisofthebreakdownofresponses
for how long RDER provided relief,
shows that 59 per cent of patients
responded that they got at least four
hours’ relief from the drop; the single
largest response being from the 35 per
cent of patients who gained 6-8 hours
of relief, followed by the 26 per cent
achieving 4-6 hours.
Patients were asked about the dry
eye symptoms they experienced and
their prevalence during the day both at
dispensing before using RDER and at
thefollow-upvisithavingusedthenew
drop. Figure 7 shows data for symptom
prevalence early in the day and late in
the day. It can be seen that there is a
trend for RDER users to experience
symptoms less often at both times of
the day. Of particular note is the 50 per
cent of users who, following RDER
use, had no symptoms early in the day,
as well as the five-fold reduction (24
at dispensing vs five at follow-up) in
patients reporting they often have
symptoms late in the day.
Patients who had used drops before
were then asked how their symptom
relief compared with their previous
drops. Eight out of 10 (n=35) patients
felt RDER was better early in the day
with no patients feeling their old drops
were better. Late in the day 74 per cent
(n=31)ofpatientsfeltthenewdropwas
betterwithonlyonepatient(3percent)
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feeling their old drop was better.
Liketheinvestigators,thepatientsalso
recorded their agreement with a series
of statements on their views following
using RDER. The patients’ opinions for
six performance statements for the 35
patients who completed the study can
be seen below:
● ‘ RDER rapidly soothes and
moisturises my dry eyes’ – 88 per cent
of all patients strongly agreed (40 per
cent) or agreed (48 per cent) with this
statement. Only one patient disagreed
(3percentstronglydisagreed)withthis
proposition
● ‘RDER provides rapid relief from dry,
gritty eyes’ – 82 per cent of all patients
strongly agreed (43 per cent) or agreed
(39 per cent) with this statement. Only
onepatientdisagreed(3percentstrongly
disagree) with this proposition
● ‘RDER does NOT significantly blur
my vision after instillation’– 88 per cent
of all patients strongly agreed (34 per
cent) or agreed (54 per cent) with this
statement.Onlyone(3percent)patient
disagreed with this proposition
● ‘RDER provides long lasting relief of
my dry eye symptoms’– 63 per cent of all
patients strongly agreed (23 per cent) or
agreed(40percent)withthisstatement.
24 per cent were neutral and 14 per cent
disagreed.Nopatientsstronglydisagreed
with this proposition
● ‘RDER is more effective than other
dry eye drops I’ve tried’ – out of the 22
responses to this question, 59 per cent
of all patients strongly agreed (41 per
cent) or agreed (18 per cent) with this
statement (Figure 8). The single largest
response was the 41 per cent who
strongly agreed, with the next largest
group being the 23 per cent who were
neutralaboutthestatement.Eighteenper
cent of this group of patients disagreed
(14 per cent) or strongly disagreed (4
per cent) with this proposition
● ‘If my optician agreed, I would like
21.05.10 | Optician | 31
Clinical
money’. The overall result for both the
10ml and the DDU showed that 46 per
cent of patients strongly agree (20 per
cent) or agree (26 per cent) that RDER
represents good value for money.
Again there was variation between
the two formats; the main difference
betweenthemisthenumberofpatients
who disagree with the proposition.
Only 10 per cent of the 10ml users
disagree(5percent)orstronglydisagree
(5 per cent) that this format represents
good value for money. However, this
increases to 20 per cent for DDU users,
with 13 per cent strongly disagreeing
and 7 per cent disagreeing that at a £1
premium, the daily disposal format
represents good value for money.
to continue using RDER’ – 88 per cent
of all patients strongly agreed (47 per
cent) or agreed (41 per cent) with this
statement (Figure 9). Nine per cent
(three patients) either disagreed (6 per
cent) or strongly disagreed (3 per cent)
with this proposition.
Value for money
Patients were asked to rate their level of
agreement with the statement ‘RDER is
worth paying more for’.The overall result
for both the 10ml and the DDU shows
that55percentofpatientsstronglyagree
(15 per cent) or agree (40 per cent) that
RDER is worth paying more.
Interestingly there was a variation
between responses for the two formats.
The DDU divided opinion more than
the 10ml format, with an increase to
just over a fifth (21 per cent) of patients
strongly agreeing that this format is
worth paying more for. However, the
numberdisagreeingwiththeproposition
more than doubled to 22 per cent being
the second most popular response.
Patients were also asked to rate their
level of agreement with the statement
‘RDER represents good value for
32 | Optician | 21.05.10
Discussion
Dry eye studies are notoriously difficult
and expensive to perform, with the
gamutoftestsavailablealsolesssensitive
than researchers would ideally like.
Many studies struggle to demonstrate
any clinically or statistically significant
improvement or differences between
products.
Increasingly experts in the dry
eye field advise practitioners to
listen to their patients more when it
comes to diagnosing dry eye. Patient
symptomatologyisimportantinhelping
understandthecondition’slikelycause
and thus management. In the author’s
view is often more helpful than many
of the quantitative tests that, if they are
conclusive at all, at best simply confirm
whethertheeyeisdry,ratherthanwhat
might be the underlying problem.
Aspractitioners,wetendtobeslightly
sceptical of manufacturers’claims until
we have ‘tested’ them for ourselves
with our own patients. This paper
reviews the experience of patients in
the same ‘real world’ environment
that any practitioner, who decides to
trial a product in his or her practice,
will experience. This kind of patient
feedbackisavaluableandperfectlyvalid
way of evaluating the performance of a
dry eye drop such as RDER.
As clinicians, we like to discuss our
experiencesandgettheperspectiveof
our peers, even though we know this is
simply anecdotal. This post marketing
field study provides UK practitioners
with the views of 10 of their peers, as
well as 35 of their patients using RDER
on a random mix of mild to moderate
dryeyepatients,somewithexperience
of using eye drops, that presented in
their regular clinics. Thus, while not
as scientific in its protocol as a study
carriedoutinaresearchclinic,itmirrors
the real world, making its results a valid
indicator of product performance.
Conclusion
It can be seen that the results from
both groups were generally positive
towards RDER, with the responses
from patients better (perhaps not
surprisingly) than the naturally
more conservative investigators.
However all 10 practitioners agreed
to stock the product as a result of their
experience with it and, in all but one
instance, weren’t unhappy for any
of their patients to continue to use it.
Interestingly,andperhapssurprisingin
the light of current opinion, 90 per cent
ofthepractitionerresponsesfeltthatthe
use of the preservative in the multidose bottle didn’t negatively affect the
performance of the drop.
Patientsinthestudywereverypositive
about the benefit of using RDER, with
all of them agreeing that it provided
some kind of relief and three quarters
responding with a definite ‘Yes’ to the
question ‘Did the drops relieve your
dry eye symptoms?’. Certainly there
was strong agreement that it provides
both rapid relief, more than a four-fold
reduction in dryness symptoms, a
six-timesincreaseinpreviousdropusers
sayingitprovidedlong-termreliefanda
five-foldreductioninpatientsreporting
symptoms late in the day.
In commercial clinical practice, the
final ‘proof of the pudding’ is purchase
intent and perceived value for money,
once the price of the product is known.
Thesedatawerestrongandparticularly
impressive was the fact that over half
of the patients (55 per cent) also agreed
that the performance of RDER was
worth paying more for.
The technology behind dry eye
preparations is improving all the time
and the results of this post marketing
field study suggest that RDER provides
UK practitioners with another
effectiveproducttohelpthemmanage
the increasing number of patients
complaining of ocular dryness during
their everyday lives. ●
Acknowledgements
The author and The Mentholatum Company
would like to thank the following individuals
for their support and diligence in carrying
out this study: Ian Moss, Christine Ramsdale,
Finlay Rosenburg, Ian Hickson. Kieran Minshull,
Stephen Saum, Sarah Farrant and Kay Hilton.
Reference
1 Atkins N. Managing Dry Eye Disease (A
Review of Rohto Dry eye Relief). Optician,
11.12.09 page 22-23.
● Nick Atkins is professional affairs
and marketing consultant and director of
positive impact
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