ARTICLE
A Comparative Study Between an Oil-in-Water Emulsion and
Nonlipid Eye Drops Used for Rewetting Contact Lenses
Sarah E. Guthrie, Ph.D., Lyndon Jones, F.C.Optom., Ph.D.,
Objectives: The purpose of this study was to determine the clinical impact
of using SYSTANE BALANCE Lubricant Eye Drops (Alcon, Fort Worth,
TX), an oil-in-water emulsion, as a rewetting eye drop in symptomatic
contact lens wearers.
Methods: Subjects who had previously experienced contact lens discomfort
(CLD), with a mean lens wearing history of 18.6612.8 years, were ran-
domly assigned to use a Test (SYSTANE BALANCE Lubricant Eye Drops;
n¼76) or control (habitual nonlipid contact lens rewetting eye drop; n¼30)
drop over their contact lenses within 5 min of lens insertion and then sub-
sequently at 2 hr intervals up to a maximum of 4 drops per eye daily for a 1-
month period. Assessments of subjective comfort, comfortable wearing
time, lid wiper epitheliopathy (LWE), and corneal staining were conducted
at baseline and after 1 month, after 6 hr of lens wear.
Results: Comfort, wearing time, LWE, and corneal staining all showed
statistically significant improvements in the test group using SYSTANE
BALANCE Lubricant Eye Drops at the 1-month visit compared with
baseline data (all P,0.01) and compared with the control group at the
1-month visit (P,0.01, P¼0.01, P,0.01, and P¼0.03, respectively).
Conclusions: The use of SYSTANE BALANCE Lubricant Eye Drops as
a rewetting drop in a group of wearers who experienced symptoms of CLD
improved subjective comfort scores, increased comfortable wearing time,
and reduced signs of LWE and corneal staining, when compared with the
use of non–lipid-containing contact lens rewetting eye drops.
Key Words: Rewetting eye drops—Contact lens discomfort—Lid wiper
epitheliopathy—SYSTANE BALANCE lubricant eye drops—Lipid
rewetting eye drops.
(Eye & Contact Lens 2015;41: 373–377)
D iscontinuation of contact lens wear has been reported at
between 12% and 51% of contact lens wearers,1–5 with
contact lens discomfort (CLD) as the leading cause,1,5 and tempo-
rary discontinuations of up to 2 years or longer range from 30% to
50% of wearers.2,6,7 It has been suggested that up to 3,000,000
contact lens wearers in the United States alone will drop out of
lens wear every year.8
Recently, the Tear Film and Ocular Surface Society addressed
this important area by conducting the TFOS International
From the Centre for Contact Lens Research (S.E.G., L.J.), School of
Optometry and Vision Science, University of Waterloo, Waterloo, Canada;
Ocular Research of Boston Inc. (C.A.B., D.R.K.), Boston, MA; and
TearScience Inc. (C.A.B., D.R.K.), Morrisville, NC.
The authors have no funding or conflicts of interest to disclose.
Address correspondence to Donald R. Korb, O.D., 400 Commonwealth
Avenue, Unit #2, Boston, MA 02215; e-mail: drkorb@aol.com
Accepted January 6, 2015.
DOI: 10.1097/ICL.0000000000000138
Eye & Contact Lens  Volume 41, Number 6, November 2015
Copyright @ Contact Lens Association of Opthalmologists, Inc. Unauthorized reproduction of this article is prohibited.
Caroline A. Blackie, O.D., Ph.D., and Donald R. Korb, O.D.
Workshop on CLD. Their findings confirmed that discomfort
was a primary reason that patients abandon wearing contact
lenses.9 Contact lens discomfort was defined as “a condition char-
acterized by episodic or persistent adverse ocular sensations related
to lens wear with or without visual disturbance, resulting from
reduced compatibility between the contact lens and the ocular
environment, which can lead to decreased wearing time and dis-
continuation of contact lens wear.”10 The workshop discussed
many possible causes of CLD associated with contact lens wear,1
among them a decrease in prelens tear film thickness,11,12 reduced
tear film stability,11–17 and reduced lipid layer thickness.9,11
Although much attention has been paid to changing the lens
material or care system to alleviate CLD,18 there is growing aware-
ness that the development of a healthy ocular surface and tear film
is vital to contact lens success.19–21 It is possible that products
intended for use in the management of dry eye could be valuable
in the management of CLD, but to date, little attention has been
paid to this concept. One such product, SYSTANE BALANCE
Lubricant Eye Drops, has been shown to be successful in the
treatment of dry eye22–25 and was formulated to manage evapora-
tive dry eye associated with meibomian gland dysfunction.22 Con-
tact lens wear disturbs the tear film and results in evaporative dry
eye,26 and thus an eye drop aimed at improving tear film stability
by supplementing the lipid layer may be an appropriate manage-
ment option. SYSTANE BALANCE contains a unique metastable
microemulsion (LipiTech) of two oils, a mineral oil and a polar
phospholipid surfactant (dimyristoyl phosphatidylglycerol), in
addition to propylene glycol, hydroxypropyl guar, borate, and sor-
bitol. These neutral oils and phospholipids function to increase
lipid layer thickness and stability by anchoring the neutral oils to
the aqueous layer, thus minimizing evaporation.27 The high–
molecular weight hydroxypropyl-guar molecules, along with the
natural mucins, prolong the retention of the demulcents on the
lens27 and stabilize the tear film.
The purpose of this study was to determine the clinical impact of
using SYSTANE BALANCE Lubricant Eye Drops as a rewetting
eye drop in symptomatic contact lens wearers for comfort, wearing
time, lid wiper epitheliopathy (LWE), and corneal staining.
METHODS
Study Design
This study was a prospective, nonsignificant–risk open-label
randomized parallel-group clinical trial of SYSTANE BALANCE
Lubricant Eye Drops (Alcon Laboratories, Fort Worth, TX), an oil-
in-water emulsion, used as a rewetting eye drop with soft contact
lenses, when compared with nonlipid-based contact lens rewetting
373
 S. E. Guthrie et al.
eye drops. Ethics clearance was obtained through an independent
clinical research ethics committee, before commencement of the
study, and informed consent was obtained from all participants before
enrollment in the study. All participants were recruited from a single
practice in Boston, MA. Participant eligibility was determined at
a screening visit according to the inclusion and exclusion criteria.
Participants were assessed at a baseline visit and after 1 month of
eye drop use. At the screening visit, a baseline examination was
conducted to qualify the participant, obtain the required data, and if
appropriate, initiate the study with those contact lens wearers who
met the prerequisites and the inclusion criteria. This visit was
scheduled at the end of the participant’s maximum wearing time, or
after a minimum of 6 hr of wearing, to evaluate LWE and corneal
staining. The follow-up visit, which was also the exit visit, was
conducted 1 month (between 21 and 35 days) after the baseline
examination. As with the screening visit, this visit was scheduled at
the end of the participant maximum wearing time, or after
a minimum of 6 hr of wearing, to evaluate LWE and corneal
staining. The investigator was masked from knowing if the partic-
ipant had been using the Test (SYSTANE BALANCE) or control
(non–lipid-containing) eye drops.
Participants
A total of 115 participants were enrolled into the study and
randomized into 2 groups (Test: n¼80, control: n¼35). Nine of these
participants were discontinued from the study before completion of
all follow-up visits. The remaining 106 participants completed both
visits (baseline and 1 month): 76 in the Test group (mean age,
42.9613.6 years; range, 21–73 years) and 30 in the control group
(mean age, 45.0615.6 years, range 24–73 years). The mean number
of years of contact lens wear for all participants was 18.6612.8
years and was not statistically significantly different between groups
(Test group, 18.0612.2 years; control group, 20.1614.5 years;
P¼0.24). To be eligible, all participants needed to be experiencing
symptoms of CLD; be 18 years of age or older, be habitual wearers
of reusable soft contact lenses from Food and Drug Administration
groups 1, 4, or 5; be currently using a nonlipid contact lens rewetting
eye drop on an ongoing basis; and have otherwise healthy normal
eyes, eyelids, and vision. Participants also needed to have a habitual
contact lens wearing time between 2 and 8 hr, which they reported to
be shortened by their experiencing CLD, and be able to wear their
lenses for 6 hr before the baseline and 1-month assessments.
Study Products
Participants continued to use their habitual soft contact lenses
during the study, which included a cross section of hydrogel and
silicone hydrogel monthly and biweekly replacement lenses, from
TABLE 1. Rewetting Drops Use by the Control Group
Generic ReNu MultiPlus
Rewetting Refresh Lubricating and
Dropsa Contacts Rewetting Drops
Manufacturer Various Allergan Bausch & Lomb Abbott Medical Optics
No. control 11 4 4
participants
a
Store brand.
b
This is a rigid lens rewetting drop and was used off-label (·1 with Biomedics 38 and ·2 with Acuvue Advance).
374
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Eye & Contact Lens  Volume 41, Number 6, November 2015
Food and Drug Administration groups 1 and 4 (hydrogel materials)
and group 5 (silicone hydrogels). This study design was used to
ensure a broad distribution of lenses so that results would be most
applicable to clinical practice. Participants in the Test group used
SYSTANE BALANCE Lubricant Eye Drops as a contact lens
rewetting eye drop. Participants in the control group continued to
use their habitual nonlipid contact lens rewetting eye drop during
the study (Table 1).
Participant Instructions
Participants were instructed to instill their assigned contact lens
rewetting eye drop within 5 min of insertion of the lenses and
subsequently at 2 hr intervals. Instructions given to participants
were to depress the lower lid and place the drop in “the pocket”
created between the eye and the lid and then close the eye for 5 sec.
The maximum dosage for each eye was 4 drops on any 1 day. If
contact lenses were not worn on a given day, participants were
asked to still use their assigned eye drop 4 times per day in both
eyes. Participants were instructed on the importance of compliance
at the baseline visit and then asked again if they had followed
instructions when seen at 1 month. All reported that they had been
compliant with the eye drop regimen.
Subjective Comfort Assessment
Participants were asked to rank their comfort when wearing
lenses on a 5-point scale, where 1 represented optimal wear and no
symptoms, and 5 represented intolerable discomfort to the point of
precluding contact lens wear (Table 2), at baseline and after 1
month of eye drop use. Participants were not prompted and were
instructed to grade their comfort while wearing lenses using the
letter grading of A, B, C, D, and F, as this grading system is readily
understood. Participants who at baseline gave a comfort grade of C
or D with their habitual lenses and eye drops were eligible for
inclusion in the study.
Contact Lens Wearing Time Assessment
Participants were verbally asked “What is the average time you
can wear your lenses before discomfort requires you to remove
lenses?,” and their responses were recorded.
Grading of Lid Wiper Epitheliopathy
Lid wiper epitheliopathy was evaluated using previously
described methods.28 Based on previous studies,29–32 fluorescein
and lissamine green were used for the detection of LWE. A
40-mL drop of an unpreserved mixture of equal volumes of 2%
and 1% lissamine green was instilled into the conjunctival sac of
both eyes. After 5 min, a second drop of 2% fluorescein and 1%
Blink Contacts Optimum by Lobob Boston Opti-Free
Lubricating Wetting and Rewetting Replenish/Express
Eye Drops Rewetting Drops Dropsb Rewetting Drops
Lobob Laboratories Bausch & Lomb Alcon
3 2 3 3
Eye & Contact Lens  Volume 41, Number 6, November 2015
 Eye & Contact Lens  Volume 41, Number 6, November 2015 Rewetting Contact Lenses

TABLE 2. Descriptive Text Supplied to Participants to Assist Them Data Analysis

With a Subjective Rating of Contact Lens Comfort
Comfort
Rating Grade Description
A 1 Contact lenses and eyes feel great—no feeling!
B 2 Contact lenses and eyes comfortable—contact lenses
are like wearing comfortable shoes, if told to remove
them when you arrive home, you would forget half
the time
C 3 Aware of contact lenses and eyes—analogy—like
wearing dress shoes, the contact lenses are tolerable,
but you would take them off as soon as you got
home
D 4 Contact lenses and eyes uncomfortable—analogy—you
would only wear the shoes to an important party and
remove them as soon as possible
F 5 Eyes intolerable—you would be unable to wear the
contact lenses
lissamine green was instilled. One minute after the second drop, the
upper eyelid was everted with great care to avoid contact with the
region of the lid wiper. Examination of the lid wiper region for
fluorescein and lissamine green staining was conducted with a sli-
tlamp using ·16 magnification and included a region defined by the
horizontal length of the lid wiper, extending from the superior
punctum to the lateral canthus, and the vertical height (width) of
the lid wiper, extending from just proximal to the line of Marx to
the subtarsal fold. The fluorescein staining of the lid wiper was
graded from grade 0 to 3 for the stained horizontal length and the
average stained sagittal height (width). This was repeated for the
grading of lissamine green staining. The average of the individual
grades for these two findings was taken for a final staining grade
for the lid wiper of each eye.
Corneal Staining
A slitlamp using ·16 magnification was used to examine the
ocular surface for corneal staining. The severity of corneal staining
was graded using a zero (no staining) to three (severe) grading
scales in half-step increments for the entire cornea.
Statistical analysis was conducted using Statistica 12 (StatSoft
Inc., Tulsa, OK). All data are reported as mean6SD. Wilcoxon
matched-pair tests were used to evaluate dependent changes over
time (baseline vs. 1 month). The Mann–Whitney U test was used to
compare variables between groups. Statistical significance was set
at 5% for each variable.
RESULTS
Subjective Comfort
Participants were asked to grade the comfort of their lenses using
the letter grade system A to F at both baseline and 1-month visits
(Table 3) (Fig. 1). There was a statistically significant improvement
in comfort scores in the Test group after the use of the Test rewet-
ting eye drop (P,0.01), with 52 of the 76 participants (68%)
showing an improvement in comfort score. The Test group also
showed significantly better comfort scores than the control group at
the 1-month visit (P,0.01), where only 11 of 30 participants
(37%) showed improvements in comfort scores.
Wearing Time
Participants were verbally asked “What is the average time you
can wear your lenses before discomfort requires you to remove
lenses?,” and their responses were recorded to the nearest hour
(Table 3) (Fig. 2). Both the Test and control groups showed a sta-
tistically significant improvement in mean wearing time between
the baseline and 1-month visit (both P,0.01). However, the Test
group showed a statistically significantly longer average wearing
time than the control group at the 1-month visit (P¼0.01). In the
Test group, 59 of 76 participants (78%) reported an increase in
wear time, and of those, 52 reported an increase of 2 or more hr.
Lid Wiper Epitheliopathy
Lid wiper epitheliopathy was assessed at both baseline and 1-
month visits (Table 3). The Test group showed a statistically sig-
nificant improvement in LWE between the baseline and 1-month

TABLE 3. Mean and SD Values of Subjective Comfort (1–5), Mean Wearing Time (Hr), LWE (0–3) and Corneal Staining (0–3) at Baseline and
1-Month Visits
Test Control

n Mean6SD n Mean6SD Pa

Comfort (1–5)
Baseline 76 3.460.5 30 3.560.5 0.43
1 month 76 2.360.9 30 3.261.0 ,0.01
Pb ,0.01 0.20
Mean wearing time (hr)
Baseline 76 4.361.8 30 4.161.9 0.53
1 month 76 6.662.8 30 5.062.1 0.01
Pb ,0.01 ,0.01
LWE (0–3)
Baseline 71 1.060.7 26 1.360.7 0.07
1 month 71 0.560.6 26 1.260.7 ,0.01
Pb ,0.01 0.22
Corneal staining (0–3)
Baseline 76 0.860.6 30 1.060.6 0.22
1 month 76 0.660.5 30 0.960.7 0.03
Pb ,0.01 0.12
a
Mann–Whitney U Test comparing Test and control.
b
Wilcoxon matched-pairs signed-ranks test comparing baseline and 1 month.
LWE, lid wiper epitheliopathy.

© 2015 Contact Lens Association of Ophthalmologists 375

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 S. E. Guthrie et al.
FIG. 1. Graph showing mean6standard error for lid
wiper epitheliopathy (0–3), corneal staining (0–3),
and comfort (1–5, where 1 represents optimal wear
and no symptoms, and 5 represents intolerable to the
point of precluding contact lens wear) at baseline and
1 month.
visit (P,0.01). The Test group also showed a statistically signif-
icantly lower LWE than the control group at the 1-month visit
(P,0.01).
Corneal Staining
Corneal staining was assessed at both baseline and 1-month
visits (Table 3). There was a statistically significant improvement
in corneal staining in the Test group between the baseline and 1-
month visit (P,0.01). The Test group also showed statistically
significantly lower corneal staining scores than the control group
at the 1-month visit (P¼0.03).
DISCUSSION
All participants in the study experienced CLD, which shortened
the amount of time they could wear their habitual contact lenses.
The objective of this study was to evaluate the performance of
a lipid-based dry eye product (SYSTANE BALANCE Lubricant
Eye Drops) as a contact lens rewetting eye drop, as compared with
nonlipid contact lens wetting eye drops, on comfort, wearing time,
LWE, and corneal staining. This study is the first to examine the
use of SYSTANE BALANCE as a contact lens rewetting eye drop.
A previous study in patients with dry eye associated with
meibomian gland dysfunction showed a statistically significant
FIG. 2. Histogram of reported average
contact lens wearing time at the base-
line visit and after 1 month of eye drop
usage for the Test (n¼76) and control
(n¼30) groups.
376
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Eye & Contact Lens  Volume 41, Number 6, November 2015
improvement in corneal staining and tear break-up time, and 61%
of participants preferred SYSTANE BALANCE to their habitual
eye drop.22 Other studies have shown participants using SYS-
TANE BALANCE Lubricant Eye Drops have a statistically signif-
icant increase in lipid layer thickness versus a glycerin-based
control eye drop and significantly better comfort versus a mineral
oil–based control eye drop.24
The results of this study indicate that using a lipid-based eye
drop such as SYSTANE BALANCE as a contact lens rewetting
eye drop can provide improvements in both clinical signs and
symptoms in a group of soft lens wearers with symptoms of CLD,
when compared with a subset of the contact lens rewetting eye
drops currently on the market. Primary outcome variables,
including comfort, wearing time, LWE, and corneal staining, all
showed statistically significant improvements in the group using
SYSTANE BALANCE at the 1-month visit compared with
baseline data (all P,0.01) and compared with the control group
at the 1-month visit (P,0.01, P¼0.01, P,0.01, and P¼0.03,
respectively). In the Test group, 67% of participants experienced
an improvement in comfort, and the mean wearing time increased
by more than 2 hr.
The control drops act merely as a rewetting agent and do not
contain components designed specifically to stabilize the tear film
and reduce evaporation. If CLD is tied to improved tear film
Eye & Contact Lens  Volume 41, Number 6, November 2015
 Eye & Contact Lens  Volume 41, Number 6, November 2015
stability,19–21 then the control drops may only cause a short-term
improvement in comfort, leading to the slight, but not statistically
significant, improvement in comfort in the control group. Corneal
staining may have been reduced through an improvement in tear
film stability on both the cornea and over the lens surface, which
have been demonstrated in previous studies.22,27 A more stable tear
film would be expected to reduce the interaction between the ante-
rior lens surface and palpebral conjunctiva, which would be ex-
pected to reduce LWE.33 A more stable prelens tear film would also
be expected to improve lens comfort and wearing time, as demon-
strated in this study. However, future studies should ideally mea-
sure both tear film thickness and break-up time to confirm this
concept.
It should be noted that with any open-label study, there is
a potential bias for participants to subjectively prefer the Test
eye drop. However, although subjective data may be influenced,
the results also showed improvements in objective measures. As
the investigator was masked at the 1-month visit, these measures
should be free from bias. It should also be noted that because
habitual lenses and habitual rewetting eye drops were not
controlled in this study, it is hard to draw conclusions as to
how the eye drop would perform when used with market-leading
lenses against market-leading rewetting eye drops. This in no
way detracts from the promising results of this study, and a broad
cross section of habitual lenses across Food and Drug Admin-
istration groups 1, 4, and 5 allows for the eye drop effectiveness
to be assessed with many different materials simultaneously.
However, further work is required to determine if the effects of
using SYSTANE BALANCE as a contact lens rewetting eye
drop are as pronounced in a more targeted study, where the
study lenses and control eye drop are standardized to remove
variability.
ACKNOWLEDGMENTS
The authors thank Dominik Papinski for statistical assistance.
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