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Results of a Community-Based Evaluation of a Lubricant Eye Drop
Ilan Hartstein, MD and Steven Khwarg, MD
With many tear supplements available, it is increasingly important that their
clinical efficacy be assessed under normal patient use conditions. Many patients presenting with dry eye are currently using or have used drops in the
past without relief. They desire a product which improves their symptoms perceptibly and does so within days.
Method
168 dry eye subjects were enrolled at 29 sites. Subjects were required to have
a total corneal staining score ≥ 4 (NEI corneal staining grid), with a grade ≥ 2 in
at least one zone, in one eye to be enrolled. Subjects also indicated that their
eyes “felt dry enough to want to use eye drops” at least “some of the time”.
Eligible subjects were given a run-in drop to use QID for 7 days, and then examined (baseline, day 0). Subjects continuing to meet the inclusion criteria
were then given Systane® Lubricant Eye Drops (Alcon Laboratories, Inc.) to
use QID, and reexamined on day 28. Subjects completed a diary to document
use of both the run-in and test products. At each visit, corneal and conjunctival
staining were measured for both eyes, and subjects rated severity of six ocular
discomfort symptoms on a 0- 4 scale. At days 0 and 28, subjects completed a
Likert questionnaire rating product acceptability.
This study was designed to learn about the performance of Systane® Lubricant
Eye Drops in one month of use by patients encountered in a typical practice
setting who exhibited moderate dry eye signs and symptoms.
METHODS
After 28 days of QID Systane use, there was a statistically significant reduction in corneal staining compared to baseline (p<0.0001). 94% of subjects
improved from the baseline visit, with mean reduction in total corneal staining of 4.1 (62%). Conjunctival staining improved significantly with a mean total reduction of 3.1 (59%, p<0.0001). Subjects experienced statistically significant symptomatic relief with Systane® for all six ocular discomfort severity
questions. Most notably, “dryness sensation” severity decreased from 2.4 at
screening to 1.1 (p<0.0001). There were also significant differences in favor of
Systane® for patient acceptability, with less morning and end of day dryness,
and ability to “forget my symptoms during use of the drops” (p<0.0001).
®
Conclusion
Systane effectively treated signs and symptoms associated with moderate to
severe dry eye with significant improvement in 28 days.
®
INTRODUCTION
Dry eye is the term commonly used to describe a number of conditions of the
ocular surface characterized by a tear film disorder which results from a tear
deficiency or excessive tear evaporation. The ocular surface environment is
made up of surface epithelial cells, the glycocalyx and the tear film. A breakdown in any of these components can lead to disruption of the tear film and
damage to epithelial cells. Dry eye presents as a collection of clinical signs
or symptoms or both signs and symptoms.1 Signs of dry eye commonly include corneal staining, conjunctival staining, rapid tear breakup time and low
Schirmer test scores.2 Symptoms felt by patients may include dryness, burning, grittiness, and foreign body sensation. They tend to be most intense in the
morning and the evening.3,4
The predominant treatment strategy for dry eye has been to augment tears
with tear supplements. Tear supplements attempt to wet the ocular surface
and combine the artificial tear with the patient’s existing tear layer to provide
protection. Tear supplements typically provide short-term relief because of
brief retention time on the ocular surface. This protection may be enhanced
with new technologies that provide longer retention time.
Alcon Laboratories recently introduced Systane Lubricant Eye Drops. Systane
contains polyethylene glycol 400 and propylene glycol demulcents with the
polymer hydroxypropyl guar (HP-Guar) as a gelling agent. When exposed to
the pH of the ocular surface and tears, the HP-Guar in Systane® forms a “soft”
gel with increased viscosity and bio-adhesive properties that are designed to
promote the retention of the two demulcents, protecting the ocular surface en®
-0.1, p=0.3142
10
-4.1, p<0.0001
8
6.7
6.6
6
4
Study Design
One hundred sixty eight patients with a diagnosis of moderate to severe dry
eye were enrolled at 29 ophthalmology practices in environmentally dry areas. Patient ages ranged from 23 to 90, with the median age 67. For inclusion
at the screening visit (Day -7), patients had to exhibit a total corneal staining
score in one eye of four or above, with at least one zone having a grade two
or higher in the same eye, and also had to feel the need to use eye drops at
least some of the time.
-3.1, p<0.0001
Day 0 (Baseline)
Day 28
Day 0 (Baseline) to Day 28
No Change
Corneal Staining
5%
Worse
1%
Each of five corneal zones (NEI grid; superior, nasal, central, inferior, temporal) was graded from 0 (normal) to 3 (severe) following sodium fluorescein instillation, under the slit-lamp for both eyes.
5.7
6
3
1.4
4
1.4
1
0.6
2.2
2
0
Screening
0
Screening
Day 0 (Baseline)
Day 28
Conjunctival Staining Summary
Change
-3.1*
% Change
-59%
Superior Nasal
-0.5*
-64%
Nasal
-0.6*
-50%
Inferior Nasal
-0.6*
-51%
Superior Temporal
-0.4*
-68%
Temporal
-0.5*
-58%
Inferior Temporal
-0.6*
-59%
Conjunctival Staining
Day 28
Ocular Discomfort Severity:
Foreign Body Sensation
Change from Baseline
Area
Total
Day 0 (Baseline)
Scale (0-None 1-Mild 2-Moderate 3-Severe)
2
1.4
1.3
1
0.7
0
Screening
Day 0 (Baseline)
Day 28
Scale (0-None 1-Mild 2-Moderate 3-Severe)
Ocular Discomfort Severity:
Grittiness Sensation
-0.2, p=0.0214
3
3
-0.7, p<0.0001
-1.0, p<0.0001
2.4
Better
Subjects ranked their agreement to each Likert style statement from 1 (Strongly
Disagree) to 5 (Strongly Agree). The change from baseline score is reported.
NEI Grids
Corneal Fluorescein Staining: (0 – 3 for each of 5
zones)
2
3
T
2
4
1
4
1
5
®
3
2
Change from Baseline
Change % Change
-4.1*
-62%
Central
-0.8*
-69%
Superior
-0.8*
-66%
-0.5*
Total Staining Score: (15 Maximum)
Lissamine Green Staining: (0 – 3 for each zone)
N
2
4
3
5
N
T
2
6
6
3
5
1
My eyes feel comfortable upon
instillation of drops.
My eyes feel refreshed when I use the
drops.
My eyes feel refreshed longer than
expected when I use the drops.
I frequently forgot my symptoms during
the use of the drops.
+0.5*
+13%
+0.6*
+17%
+0.8*
+28%
+0.7*
+26%
Nasal
-0.8*
-67%
Inferior
-1.0*
-55%
Holly FJ, Lemp MA. Tear Physiology and Dry Eyes. Survey of Ophthalmology 1977;22(2):69-87.
2
Christensen MT, Cohen S, Rinehart J, et al. Clinical Evaluation of an HPguar Gellable Lubricant Eye Drop for the Relief of Dryness of the Eye. Current Eye Research, 2004: 28(1), p55-62.
3
Doughty MJ, Fonn D, Richter D, et al. A Patient Questionnaire Approach to
Estimating the Prevalence of Dry Eye Symptoms in Subjects Presenting to
Optometric Practices Across Canada, Optometry & Vision Science, 1997,
74:624-31.
4
Begley CG, Caffrey B, Chalmers RL , Mitchell GL. Use of Dry Eye Questionnaire to measure symptoms of Ocular Irritation in Subjects with Aqueous Tear Deficient Dry Eye. Cornea 2002;21 (7):664-670.
5
Asgharian B, Nolen L, Meadows D, and Stone R, Novel Gel-forming Ophthalmic Polymer System for Artificial Tear Solution. Abstract #2472 ARVO
Meeting, May 2003.
1
1
1
0.6
0
Screening
Day 0 (Baseline)
Day 28
Scale (0-None 1-Mild 2-Moderate 3-Severe)
0
Screening
Ocular Discomfort Severity:
Burning Sensation
Day 0 (Baseline)
Day 28
Scale (0-None 1-Mild 2-Moderate 3-Severe)
Ocular Discomfort Severity:
Stinging Sensation
-0.1, p=0.0575
3
-0.1, p=0.5856
3
-0.6, p<0.0001
1.6
1.5
1
2
1.2
0.7
1.1
1
4
-22%
1.3
2
O.S. _____
T
1.1
-66%
5
O.D. _____
1
Corneal Staining Summary
Temporal
-0.9*
REFERENCES
2
-0.8, p<0.0001
T
My eyes feel dry at the end of the day.
2.1
94%
Area
Total
-19%
• An improvement in ocular signs, both corneal and conjunctival staining,
was observed in subjects using Systane® for 28 days.
• Ninety-four percent (94%) of subjects using Systane® had a lower total corneal staining score at Day 28. Corneal staining decreased by 4.1 units at
Day 28, a 62% decrease from baseline (p<0.0001).
• Conjunctival staining decreased by 3.1 units at Day 28, a 59% decrease
from baseline (p<0.0001).
• A decrease in symptoms typically associated with dry eye was seen after
28 days of QID Systane® use, including dryness, burning, scratchiness,
foreign body sensation, grittiness, and stinging.
• Increased comfort was shown with Systane® use, as indicated by the subjects’ responses to Likert style acceptability questions.
• These results may be attributed to the action of the active ingredients
(polyethylene glycol 400 and propylene glycol) and the polymer HP-Guar
in Systane®.
• Based on these results, clinicians should consider recommending Systane®
Lubricant Eye Drops for their moderate to severe dry eye patients.
1.5
Comfort Subjective Questions
-0.8*
CONCLUSIONS
-0.6, p<0.0001
-0.3, p<0.0001
Severity of six ocular discomfort sensations was recorded on a four point scale
(0=none, 1=mild, 2=moderate, 4=severe).
My eyes feel dry in the morning.
*p<0.0001
-0.1, p=0.1080
3
Ocular Discomfort Severity:
Dryness Sensation
Ocular Discomfort Scales
% Change
-0.8, p<0.0001
5.3
*p<0.0001
Conjunctival staining was performed under the slit-lamp using lissamine green.
The degree of staining was recorded separately for six regions, three portions
of the temporal conjunctiva and three portions of the nasal conjunctiva, on a
scale of 0-3.
Change
Question
2
Scale (0-None 1-Mild 2-Moderate 3-Severe)
NaFl Corneal Staining:
Sum of Five Zones
Change from Baseline
8
Scale (0-None 1-Mild 2-Moderate 3-Severe)
2
Screening
This was an open label, multi-center, prospective design of five weeks duration.
-0.4, p=0.1533
10
2.5
0
Subjects
Results
NaFl Corneal Staining:
Sum of Five Zones
Comfort Subjective Questions
Ocular Discomfort Severity:
Scratchiness Sensation
Conjunctival Staining:
Total of Six Zones
Conjunctival Staining (sum of six zones)
The predominant treatment strategy for dry eye has been to augment tears
with tear supplements. Tear supplements typically provide short-term relief
due to brief retention time on the ocular surface. This protection may be enhanced with new technologies that provide longer retention time.
Background
RESULTS
Corneal Staining (sum of five zones)
ABSTRACT
vironment.5 The formulation of this tear supplement is preserved with POLYQUAD (0.001%) and contains the essential ions potassium, calcium, magnesium, zinc, and sodium.
*p<0.0001
0.5
0
Screening
Day 0 (Baseline)
Scale (0-None 1-Mild 2-Moderate 3-Severe)
Day 28
0
Screening
Day 0 (Baseline)
Scale (0-None 1-Mild 2-Moderate 3-Severe)
Day 28
AOA 2004