Efficacy of Topical Pilocarpine in the

Management of Primary Aqueous

Tear Deficiency: An Initial Study

Ma. Theresa B. Urriquia, MD and Jose David F. Marin, Jr., MD

Department of Ophthalmology Manila Central University Filemon D. Tanchoco Medical Foundation
Caloocan City, Philippines

Tegar Chandra B.R.

 Background
• Dry eye syndrome (DES) refers to a group of conditions characterized by
varying symptoms of ocular discomfort associated with diminished aqueous
tear production and/or excessive tear film evaporation.
• Epidemiologic studies in the United States have found that dry eye affected
as many as 17% of women and 11.1% of men. The prevalence in Asia is
reportedly higher, up to 33.7%, and this is certain to increase as the
population ages.
• Dry eye is often a frustrating clinical problem to identify because of its
varying clinical presentation and often times conflicting results as to its
appropriate treatment.
• Some patients would complain of severe ocular irritation and yet have
minimal objective signs, whereas others presented with severe DES and sight
threatening corneal complications only to have minimal complaints.
• The pathology in aqueous tear deficiencies (ATD) is the hypofunctioning of
the lacrimal gland. In most cases, the symptoms are associated with a
decrease in lacrimal gland secretion causing reduced tear volume that triggers
an inflammatory response resulting to ocular manifestations
• It is, therefore, rational to target the increase in lacrimal gland secretion as
the primary and main treatment of primary ATD while assuring prophylactic
treatment against ocular infection that can be potentially blinding.
• Pilocarpine and cevimeline, both cholinergic agonists, have been approved by
the US FDA to treat dry mouth and dry eyes in patients with Sjogren’s
syndrome.
• These medications bind to muscarinic receptors found in the exocrine glands
of salivary, sweat, lacrimal, gastric, and pancreatic glands; intestinal and
respiratory mucous cells and smooth muscle, thereby stimulating secretion
• Studies on oral pilocarpine have shown significant improvement in global
assessment of dry eyes. Due to its systemic side effects, however, its use has
not been widely accepted by patients.
 Objective

• To determine the efficacy of topical pilocarpine (0.05%)

in the management of patients with primary aqueous tear
deficiency (ATD).
 Methods
• Patients seeking consult at the outpatient department were screened for dry
eye from July 2012 to March 2013.
 The inclusion criteria
• Adult male or female at least 18 years of age;
• Schirmer’s I test ≤5 mm;
• Best-corrected monocular visual acuity of at least 20/70, with a binocular
visual acuity of at least 20/40;
• Availability of patient for follow ups.
 The exclusion criteria
• Patients receiving concurrent treatment, either systemic or topical medications, that could
affect tear production.
• Anatomical abnormalities of the periocular, lids, and adnexal tissues;
• Those with history of eye injury, infection, trauma or surgery within the previous 6 months;
• Contact lens wearer;
• Those with malnutrition;
• Diagnosed with diabetes mellitus;
• Pregnant or lactating women;
• High myopia.
• They were evaluated using the Ocular Surface Disease Index (OSDI) for
symptoms of ATD with abnormal Schirmer’s I and tear-break-up time
(TBUT) results. The eyes of each subject were randomized to either the
interventional (pilocarpine 0.05%) or the control (aqueous tear substitute)
groups given for 2 months. Results were evaluated by statistical testing at
different time intervals.
 Results
• A total of 508 patients were screened for the study and 11 patients (22 eyes)
who met the inclusion/ exclusion criteria were enrolled. The mean age for
the study population was 48.82 ± 9.96
 DISCUSSION
• Dry eye syndrome has been recognized as one of the public health problems
for decades imposing economic burden and affecting the individual’s quality
of life.
• Vast researches have been conducted to address the problem, yet other
concerns were still not met. The problem is confounded with the use of a
single class of medication regardless of the type of dry eye.
• Pilocarpine, a cholinergic agonist, binds to muscarinic receptors of exocrine
glands stimulating secretion. The effect of topical pilocapine in increasing
tear flow rate
• Topical pilocapine 0.05% was used in this study to reduce these side effects.
• This concentration was chosen based on studies in neuroophthalmology that
pilocarpine 0.1% insignificantly caused pupillary constriction among normal
eyes.
• A total of 508 patients were screened but only 11 patients (22 eyes) had
primary aqueous tear deficient dry eye, there was a predominance of females,
with mean age of 49 years and age ranging from 31 to 59.
• After instillation of topical pilocarpine 0.05%, our data showed that there
was a steady stepwise increase in mean tear flow rate as compared to baseline
(4.09 ± 1.30) and after 2 months (12.46 ± 9.02) (p <0.01).

• TBUT values from baseline and at different intervals showed no

improvement (p >0.05), indicating that pilocarpine had no effect on tear film
stability.
• There was symptomatic improvement in the OSDI scores of 80% of the
patients. One patient had no change and another had worse ocular symptoms
after treatment
• There was no change in the pupillary size of all patients after 2-month use
of topical pilocarpine 0.05%.
• The strengths of this study were its design as a prospective, controlled,
double-blind and the first research conducted employing the use of topical
pilocarpine 0.05% eye drops for stimulating tear production.
• This study, therefore, showed that topical pilocarpine 0.05% was efficacious
in increasing the tear flow rate with improved OSDI scores and has the
potential to be considered as a treatment modality in managing patients with
primary aqueous tear deficiency.
 CONCLUSSION
• After 2-month treatment with topical pilocarpine 0.05%, there was a
significant increase in mean tear flow in patients with primary aqueous tear
deficiency with improvement in OSDI scores. There was no significant side
effects noted.
TERIMAKASIH
MOHON BIMBINGAN