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Compliance Factors Associated With

Contact Lens-Related Dry Eye

Padmapriya Ramamoorthy, B.S.Optom., M.S., Ph.D, Jason Jay Nichols, O.D., M.P.H., Ph.D.
Eye Contact Lens. 2014;40(1):17-22.

Abstract and Introduction

Objective: To determine if compliance factors are associated with contact lensrelated dry eye (CLDE).
Methods: The data were derived from subject responses to a compliance survey
administered in a cross-sectional study including 100 healthy, daily (nonovernight),
experienced soft contact lens wearers (50 normal and 50 with CLDE). Classification
into normal or CLDE groups was based on Contact Lens Dry Eye Questionnaire
scores, tear breakup time, and 2 hours difference between total and comfortable
daily lens wear hours. The compliance survey queried aspects of lens care, rub and
rinse practices, lens and lens case replacement frequency, solution replacement,
and sleeping with lenses. Statistical analysis of the data was performed using
unpaired T tests, 2, and Fisher exact tests as applicable.
Results: The average age of all subjects was 24.84.4 years, and 60% were
women. Overall compliance rates were low for several variables including
recommended replacement of contact lenses (53%), rub and rinse practices (69%
and 45%, respectively), care solution topping-off (80%), and washing hands before
handling lenses (48%). However, almost no compliance factors were associated with
CLDE status, with the exception of perceived ease or difficulty with lens care, which
was rated as more difficult by the CLDE group (P=0.004).
Conclusions: Overall compliance rates with contact lens care practices are very
low, highlighting the need for more effective methods of patient education regarding
contact lens care and compliance. However, almost no compliance factors were
found to be associated with CLDE. Factors other than compliance likely play a
bigger role in CLDE.

Compliance in the context of contact lens wear is a multifaceted issue including
many factors such as good hand hygiene before handling contact lenses, adherence
to proper procedures for contact lens wear schedules, replacement schedules, and
care of the contact lenses. In prior years, good compliance was defined as the
fulfillment of three standardized criteria, namely, hand washing before lens handling,
correct use of a Food and Drug Administration (FDA)-approved care system, and
adherence to a daily wear schedule.[1] Despite clear educational resources on
contemporary contact lens care,[24] high rates of noncompliance in contact lens
wearers have been recognized for many years.[1,59] Measures to improve compliance
such as the introduction of simplified contact lens care systems, daily disposable
contact lenses (which avoid lens care altogether), and additional patient education
using various media (videos, pamphlets, etc.) seem to have had little or no effect on
patient compliance.[1016]
Contact lens wearers are noncompliant with multiple aspects of contact lens wear
despite awareness of heightened risks for potentially harmful clinical effects. [1623] For
example, only 53% to 77% contact lens wearers wash their hands before handling
their lenses[1719,24,25] and approximately 6% report unauthorized overnight wear of
lenses,[1719,24,25] despite the increased risk for contact lens contamination, microbial
keratitis and corneal infiltrates, respectively.[3042]
Violations of prescribed regimens for replacement of lens and lens care components
are currently widespread. For instance, 40% to 74% contact lens wearers do not
replace lenses per the manufacturer's recommended replacement schedule
(MRRP),[17,2629] despite anecdotal and scientific reports of compromises in vision,
comfort, contact lens complications, and moderate-to-severe corneal staining with
use of lenses beyond their MRRP.[5,4345]
In addition, recommended cleaning exercises for contact lenses such as the
performance of rub and rinse practices are also compromised. As many as 75% to
77% lens wearers report being noncompliant with rubbing their lenses, [17,46] despite
the potential risk for increased ocular bioburden. [3541,4750]Perhaps, not surprisingly,
outbreaks of infectious keratitis have occurred in recent years given that 13% to
57% contact lens wearers reported "topping off" practices and reuse of care solution.

Contact lens-related dry eye (CLDE) continues to be a major issue affecting nearly
half of all contact lens wearers.[5255] Contact lens-related dry eye and alterations of
the tear film in contact lens wearers are known to be associated with problems such
as reduced visual performance and decreased lens wearing time, which may
ultimately lead to discontinuation from contact lens wear altogether.[56
Noncompliance with proper procedures for contact lens wear and care are likely to
result in the wear of soiled and contaminated contact lenses, which may lead to
compromise in the lens wearing experience. More specifically, wearing of soiled
contact lenses could be associated with symptomatology and associated with CLDE
in the noncompliant contact lens wearer. Given the high frequency of both
noncompliance and CLDE in the contact lens wearing population, it is hypothesized
that noncompliant practices may be associated with CLDE. The objective of this
work was to determine the association between noncompliant practices with contact
lens wear and care and CLDE.

The study protocol was approved by an Institutional Review Board in accordance
with the tenets of the Declaration of Helsinki. Informed consent was obtained from
all subjects at enrollment.

This was a cross-sectional study of 132 current soft contactlens wearers. Once
subjects signed the informed consent, a review of inclusion and exclusion criteria
was conducted, which led to two screen failures. The inclusion criteria for the study
included healthy, daily (nonovernight), experienced soft lens wear of at least 1 year.
Subjects were required to be aged between 18 and 39 years (inclusive), to wear
their contact lenses for at least 6 hours per day and 5 days per week (on average)
and to have a best-corrected visual acuity of at least 20/30 in each eye. Exclusion
criteria included overnight lens wear, daily disposable lens wear, active ocular
disease, history of ocular infection, inflammation, allergy within the past 6 months,
prior corneal refractive surgery, other ocular surgery that may affect the ocular
surface, use of ocular medications containing active pharmaceutical agents involving
or affecting the ocular surface, pregnancy, lactation, and systemic disease or
medications that may affect the eye.

Extended wear of contact lenses was excluded because it is associated with a

whole host of issues on its own such as increased risk for corneal inflammatory
events, which could confound the testing of our hypothesis (in that we are not testing
for additional complications but rather the relation between noncompliance and
CLDE). Use of daily disposable lenses, although potentially useful in improving
comfort, removes the role of the contact lens and associated compliance in
question, thus negating the ability to test our hypothesis and, hence, was also
excluded in this study. Except for the abovementioned factors, no other limitations
were placed on lens replacement schedules to allow study of any potential
association between lens replacement cycle and dry eye status. Thus, subjects with
biweekly, monthly, and quarterly replacement and one conventional unplanned lens
wearers were eligible for participation in the study.
Following informed consent, the subjects were examined and classified into one of
the two groupsnormal or CLDEusing the following criteria: Contact Lens Dry
Eye Questionnaire classification,[52]fluorescein-based tear breakup time values
measured 5 minutes after contact lens removal (normal>7 seconds, CLDE7
seconds), and a difference between total average daily wear time and total average
daily comfortable wear time (normal<2 hours difference, CLDE>2 or more hours
difference). This classification after informed consent also led to a reduction in the
overall sample size of 132 to 100 analysis eligible subjects, that is, 29 subjects were
deemed ineligible because of lack of fulfillment of all 3 criteria required for
classification into either subject group and 1 subject was excluded because of ocular
disease discovered during the examination.

Compliance Assessment
A compliance survey was administered in this study and included questions on the
following: difficulty or ease with contact lens care, hand washing before handling
contact lenses, contact lens and lens case replacement frequency, use of doctorrecommended or generic care solutions, rub and rinse practices, solution
replacement and topping off practice, and unprescribed napping or overnight
contact lens wear.
Subjects were required to respond on a scale of 1 to 10 for the question on
perceived difficulty or ease of care for and cleaning their contact lenses. Questions
with "yes or no" response options included queries on whether subjects:

Rinsed their contact lenses before storage in a case;

Rubbed their lenses during cleaning;

Rubbed both front and back of lenses;

Slept with their contact lenses;

Washed hands with soap, antiseptic liquid, or wipes before inserting or removing
lenses from the eyes and

Whether their lens care system was recommended by their doctor.

Open-ended questions included queries on:

Frequency of sleeping with contact lenses;

Frequency of purchase of new contact lens solutions; and

Duration for which each side of the contact lens was rubbed and rinsed.

For the question on topping-off practices, subjects could indicate that they
occasionally, half the time, most of the time, or always topped off the solution.
Response options for the question on (actual) contact lens replacement frequency
included daily, weekly, every 2 weeks, monthly, every 3 months, every year, or other.
Response options for the (actual) frequency of contact lens case replacement
included every month, every 3 months, every 6 months, very year, never, or other.

Statistical Analysis
Statistical analyses were performed using IBM SPSS version 17.0 as described later
to test for differences in compliance characteristics between subjects classified by
group status (normal and CLDE). The 2 and Fisher exact tests were used as
appropriate for testing associations between categorical compliance variables and
CLDE status. Unpaired T tests were used for assessing differences between subject
groups on continuous variables. For categorical variables, responses for some
survey questions were collapsed to overcome problems with insufficient cell data,
particularly when a cell had less than five responses.

Age and Gender
The CLDE group was slightly older with a mean age of 25.94.9 years compared
with 23.73.7 years in the normal group (T=-2.6, P=0.01). Sixty-eight percent of the
CLDE group was women compared with 52% in the normal group ( 2=2.7,P=0.10).
Subjects who topped off care solution 50% or more of the time were approximately 3
years younger on average compared with those who never or occasionally topped
off (22.32.5 years vs. 25.14.5 years, T=-2.95, P=0.009). However, neither age nor
gender was statistically associated with any other compliance-related variable.

Overall Compliance
Overall compliance rates were low for several self-reported compliance factors. For
example, 47% subjects were not compliant with recommended contact lens
replacement and 40% were not compliant with recommended lens case
replacement. Regarding lens care regimen, 21% reported care solution topping off,
31% and 54%, respectively, were not compliant with rub and rinse practices with
their lens care regimen, and 52% did not follow proper hand hygiene practices. The
summary of these results is presented in Table 1 .

Compliance and Contact Lens Dry Eye

Analysis of categorical compliance variables did not reveal any significant
associations between compliance factors and CLDE status, and the results are
summarized in Table 1 . Compliance rates were similar between the normal and
CLDE groups for compliance with rub and rinse practices and hand hygiene before
handling contact lenses. Similarly, the percent of unprescribed napping or overnight
contact lens wear in the CLDE and normal groups were 10% and 2%, respectively.
The percent of the use of doctor-recommended lens care solutions was 54% and
64% in the CLDE and normal groups, whereas it was 26% and 20% for the use of
generic care solutions in the CLDE and normal groups, respectively. The percent of
compliance with manufacturer-recommended contact lens replacement was 56%
and 50% in the CLDE and normal groups, respectively. The accompanying 2statistic
and P values for the above comparisons are presented in Table 1 .

Table 2 provides an overview of the differences in care and contact lens wear
duration factors between the normal and CLDE groups.

Overall Compliance
The overall compliance rates among contact lens wearers were found to be low for
several factors including those related to contact lens, care solution, contact lens
case, and even basic hygiene practices. Compliance rates for several factors
including recommended replacement of contact lenses, rub and rinse practices, care
solution topping off, and washing hands before handling lenses are comparable with
the estimates from previous studies.[17,2628] Recent reports from the United States and
elsewhere highlight a disturbing continued trend of widespread noncompliance.
In fact, noncompliance rates in contact lens wearers are well above
those for other medical regimens such as adherence to physician-prescribed
treatments for systemic disorders such as HIV disease and diabetes, which range
from 25% to 44%.[22,66] The reasons for such high rates of noncompliance are unclear
with some studies citing lack of patient awareness of potential risks; however,
several recent surveys indicate contact lens wearer apathy to potential
consequences of noncompliant behavior despite awareness of risk. [20,21,23,46,67] The
current noncompliance findings indicate a need for more effective methods of patient
education and reinforcement of contact lens care and compliance. [13,14,25,68]

Compliance and Contact Lens-related Dry Eye

Difficulty or ease of contact lens care was rated as significantly lower (more difficult)
in the CLDE group, possibly indicating a difference in patient attitude toward contact
lens care. This finding may reflect that subjects with CLDE feel burdened by their
lens care regimen, which may possibly include the need for additional efforts (e.g.,
removing and reinserting lenses if dry) or the need for specialized products (e.g.,
use of rewetting drops and hydrogen peroxide-based care systems) to help alleviate
their CLDE problems. Alternatively, the perceived difficulty in lens care of the CLDE
group may also reflect that subjects with CLDE have a poor attitude or negativity
toward the lens care regimen, which may be prompted by their CLDE status. It
seems unlikely that the perceived difficulty toward lens care would lead to the
development of CLDE, particularly as subjects in this study had to exhibit both

symptoms and signs to be classified as having CLDE. In other studies on patient

characteristics such as mood, personality, and compliance, mood was not
associated with CLDE.[69] However, Carnt et al.[70] reported that patients with
personality traits of greater risk-taking propensity were associated with poor
compliance practices.
Compliance with recommended contact lens replacement was surprisingly not found
to be associated with CLDE. A previous report by Dumbleton et al. [43] suggested poor
patient-reported comfort and vision in patients wearing lenses that needed
replacement. To our knowledge, there are no other reports on compliance and dry
eye-related problems in contact lens wearers.
One other possibility to explain the lack of association between noncompliance and
CLDE status in this report is that cross-sectional study designs may not be ideal for
capturing some clinical problems from noncompliant behavior. To expand on this
idea, the ocular defense and protection mechanisms are known to be highly
redundant to maximize protection from microbial and other causes. [71,72] As a result,
the eye and ocular surface appear to be very resilient to harm from noncompliant
practices, despite increased ocular bioburden resulting from poor lens care and case
hygiene.[67,7376] However, such practices continued over a prolonged period might
increase the chance for clinical problems. Longitudinal study designs may be better
suited to capture such effects from noncompliant behavior.
Similar to dry eye in general, a multifactorial pathophysiology cannot be overlooked
in CLDE. The role of other major causative factors ranging from ocular issues, such
as tear film, lacrimal, ocular surface abnormalities, and eyelid pathological findings
including meibomian gland dysfunction, to systemic disorders or medications known
to cause ocular disturbances probably play a bigger role in the pathophysiology of

Compliance and Age and Gender

Compliance factors were not associated with age or gender in this study, consistent
with some prior reports.[27,28,62] Few other reports have identified young male contact
lens users as being more noncompliant.[29,63,70] Age-related compliance analyses also
showed very little relation between age and compliance, except that subjects who
topped off care solutions were half or most of the time slightly younger compared

with those who never or occasionally topped off. These findings are also consistent
with previous reports that identified younger subjects as being more noncompliant. [27

Based on the current study findings, only patient attitude toward contact lens
care was associated with CLDE. Because no other associations were detected,
factors other than compliance likely play a bigger role in CLDE.
The current study findings may need to be verified using a larger sample owing to
limitations in sample size characteristics. The cross-sectional study design also
poses a potential limitation as it can only associate, rather than predict, the causal
relationship between noncompliance and dry eye status in contact lens wearers.
Nevertheless, the overall compliance rates are very low across both groups in
concurrence with recent reports and highlight the need for more effective methods of
patient education or reinforcement of contact lens care and compliance.

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