OBJECTIVE: To determine the efficacy of topical pilocarpine (0.05%) in the management of patients with primary aqueous tear deficiency (ATD).
METHODS: This was a single center, randomized, double-blind, placebo-controlled clinical trial of 11 dry eye patients (22 eyes) with ATD who were screened from July 2012 to March 2013. 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.
RESULT: Topical pilocarpine 0.05% significantly increased the tear production from a Schirmer's I baseline of 4.09 mm ± 1.30 to 12.46 mm ± 9.02 after 2 months (p <0.01). Symptoms improved with noted decreased OSDI score from 33.72 ± 24.88 to 13.84 ± 8.98 (p = 0.01). There was no increase in pupil size.
CONCLUSION: 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.