comparison of efficacy of 0.05 % cyclosporine ophthalmic emulsion and artificial tear
DESCRIPTION
Comparison of Efficacy of 0.05 % Cyclosporine Ophthalmic Emulsion and Artificial Tear in Meibomian Gland Dysfunction. Pinnita Prabhasawat , MD., Nattaporn Tesavibul , MD., Wannaree Mahawong , MD. Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, - PowerPoint PPT PresentationTRANSCRIPT
Comparison of Efficacy of 0.05% Cyclosporine Ophthalmic Emulsion
and Artificial Tear in Meibomian Gland Dysfunction
Pinnita Prabhasawat, MD., Nattaporn Tesavibul, MD.,Wannaree Mahawong, MD.
Department of Ophthalmology, Faculty of Medicine Siriraj Hospital,Mahidol University, Bangkok, Thailand.
Products in the study were supported by Allergan(Thailand), Ltd.
Purpose
• To compare the efficacy of topical 0.05% cyclosporine with non-preservative artificial tear in the treatment of meibomian gland dysfunction
Methods• Prospective, double blind, randomized controlled trial • Department of ophthalmology, Siriraj hospital, Mahidol university, Bangkok, Thailand.
2007-2009
SeborrheaRosacea
Medicamentosa Aging
AndrogenDHE
Dry eyeInfection
MGD
Obstruction
Tear film instability
Change of lipid
composition
Inflammation
Inflammation
Inflam
mationInflammation
Infection
• Diseases induce MGD via inflammatory pathway. • Anti-inflammatory agent might interrupt this vicious
cycle.
• Meibomian glands secrete lipid to stabilize tear film.
• Obstructive meibomian gland dystrophy (MGD) causes tear film instability
Statistic Method : Intragroup: Paired t-test, Wilcoxon sign ranked test, Marginal homogeneity test Intergroup: Independent t-test, Mann-Whitney U test, Chi-square test
Anti-inflammatory agent
MethodsMeibomian gland dysfunction
N = 40 pts, 40 eyes (Use right eye only)
Control (20 pts)Study (19 pts)
Tear as neededTear as needed
0.05%CSA bid Tear (0.5%CMC) bid
MaskingRandomized
0 M 1 M 3 M2 M
Schirmer I test Schirmer I test
Inclusion criteria
• Symptoms- irritation- photophobia- tearing
• Signs- meibomian gland obstruction, inflammation- non-invasive tear break up time < 8 sec.
Exclusion criteria
• Age < 18 years old• Severe ocular surface
abnormalities• Topical CSA < 1 year• Oral cyclosporine,
anticholinergic within 2 months
• Immunocompromise patients
• Eye infection• Allergic to eye drop• Pregnancy or
lactation• Contact lens wearerStop med due to burning
1 case
Examine every 1 M
Examinations • OSDI score• Lid inflammation • Meibomian gland secretion and expressibility• Conjunctival injection • Corneal staining • Non-invasive (tear scope) and fluorescein tear break up
time
score 0 1 2 3 4
• Lid inflammation
No Mild Moderate Severe -
• Conjunctival injection
No Mild Moderate Severe -
• Meibomian gland secretion
Clear fluid Cloudy fluid Cloudy particulate
Toothpaste-like No secretion
• Meibomian gland expressibility
Excellent >2/3 1/3-2/3 express < 1/3-total occlusion
-
• Corneal staining
Fluorescein( 0-15 )
Rose Bengal( 0-15 )
Severity grading
Signs & Symptoms CSA ( N=19 ) Control ( N=20 )
• Female: Male 16:3 15:5
• Lid inflammation - no inflammation - mild inflammation - moderate inflammation
5104
3143
• Meibomian gland secretion - clear fluid - cloudy fluid - cloudy particulate fluid - inspissated, toothpaste-like - no secretion
38521
19811
• Expressibility of meibomian gland - 2/3 expressibility - 1/3-2/3 expressibility - <1/3-total occlude
4123
3134
• Bulbar conjunctival injection - no injection - mild injection - moderate injection
1621
1550
• Tarsal conjunctival injection - no injection - mild injection - moderate injection - severe injection
01540
11360
• Corneal fluoresceine stain score 1.74 2.75
• Corneal Rose Bengal stain score 0.21 1.0
• Non-invasive tear break-up time (TBUT) (sec.) 2.23 2.24
• Fluoresceine tear break-up time (sec.) 2.32 2.05
• Schirmer’s I test (mm.) 19.26 19.20
• OSDI score 42.65 37.25
Baseline : no significant among both groups
No significant among both groups
Baseline Month 1 Month 2 Month 30
0.5
1
1.5
2
2.5
3
3.5
4
CSA Control
Baseline Month 1 Month 2 Month 30
0.5
1
1.5
2
2.5
3
3.5
4
4.5
CSA Control
Non
-inva
sive
tear
bre
ak u
p tim
e (s
ec.)
P < 0.01 P < 0.01
Non-invasive tear break up time(Tear scopeR)
Fluorescein tear break up time(2 m)
#
#
Fluo
resc
ein
tear
bre
ak-u
p tim
e (s
ec.)
#
#
#
#
CSA : Significant TBUTfrom baseline
: Significant > Control p < 0.01 intragroup# p < 0.05 intergroup
Baseline Month 1 Month 2 Month 30
5
10
15
20
25
30
35
40
45
CSAControl
OSD
I sco
reOcular Surface Disease Index (OSDI)
Symptoms improve from baseline at 2, 3 M in both groups
P < 0.01 +
+
No different among both groups , + p < 0.01 intragroup
Corneal staining
Baseline Month 1 Month 2 Month 30
0.5
1
1.5
2
2.5
3
CSA Control
Cor
neal
Flu
ores
cein
e st
ain
scor
e
Baseline Month 1 Month 2 Month 30
0.2
0.4
0.6
0.8
1
1.2
CSA Control
Cor
neal
Ros
e B
enga
l sta
in s
core
Baseline Month 317
18
19
20
21
22
23
CSA
Control
Schirmer I test
Tear
vol
ume
bySc
hirm
er I
test
(mm
)
No significant from baseline
No significant among groups
CSA Control CSA Control CSA Control CSA Control02468
10121416
no inject
mild inject
mod.inject
severe inject
Conjunctival injection
CSA Control CSA Control CSA Control CSA Control05
1015
20
no inject
mild inject
mod.inject
Baseline Month 2 Month 3
Bul
bar
inje
ctio
nTa
rsal
in
ject
ion
Month 1
No different among both groups and from base line
CSA : Significant improvement from baselineP < 0.05
+
+
+
CSA Control CSA Control CSA Control CSA Control0
5
10
15no inflam
mild inflam
mod.inflam
severe inflam
Lid margin inflammation CSA : Significant improvement from baseline
+ +
P < 0.05
Num
ber o
f pat
ient
s
, + p < 0.05 intragroup
CSA Control CSA Control CSA Control CSA Control02468
10121416
well express
2/3 express
1/3-2/3 express
<1/3-total occlude
CSA Control CSA Control CSA Control CSA Control02468
101214
clear fluid
cloudy fluid
cloudy particulate fluid
toothpaste-like
no secretion
No different among both groups. No improvement in both groups
CSA : Significantly improvement from baseline
Meibomian glandS
ecre
tion
Exp
ress
ibili
ty
Baseline Month 1 Month 2 Month 3
P < 0.05
#
p < 0.05 intragroup# p < 0.05 intergroup
Discussion • Cyclosporine (CSA) : T-cell modulator, decrease
inflammatory cytokine eg. Interleukin-6¹• Topical CSA in dry eye can improve²´³
- OSDI- Tear film stability, increase TBUT- Schirmer score- Goblet cell
• Topical CSA in MGD can improve⁴- Lid margin inflammation- Tarsal conjunctival injection- Fluorescein staining
References
1. Turner K, et al. Interleukin-6 levels in the conjunctival epithelium of patients with dry eye disease treated with cyclosporine ophthalmic emulsion. Cornea 2000;19:492-6.
2. Sall K, et al. Two Multicenter, Randomizied Studies of the Efficacy and Safety of Cyclosporine Ophthalmic Emulsion in Moderate to Severe Dry Eye Disease. Ophthalmology 2000;107:631-9.
3. Kunert KS, et al. Analysis of topical cyclosporine treatment of patients with dry eye syndrome: effect on conjunctival lymphocytes. Arch Ophthalmol 2000;118:1489-96.
4. Perry HD, et al. Efficacy of Commercially Available Topical Cycolsporine A 0.05% in the Treatment of Meibomian Gland Dysfunction. Cornea 2006;25:171-5.
• Tear break up time• OSDI score• Lid margin inflammation• Tarsal conjunctival injection• MGD expressibility
Conclusion from this study
From baseline
• Topical 0.05% CSA twice daily demonstrated superior effects over a non-preservative artificial tear in the treatment of meibomian gland dysfunction with tear film instability by increasing TBUT and improving MG function during the treatment
Topical 0.05%CSA could improve tear film stability in MGD patients with or without aqueous tear deficiency.
• OSDI score
Control: significantly improveCSA : significantly improve