Abstract
Purpose: :
To evaluate the efficacy and safety of oral pilocarpine (Salagen® Tab. 5mg) administration to the patients with both aqueous-deficient dry eye and evaporative dry eye.
Methods: :
Nineteen cases of aqueous-deficient dry eye patients and 8 cases of evaporative dry eye patients were randomized to receive 5mg to 15mg oral pilocarpine for 4 weeks. All participants were evaluated at baseline and each visit of week 1, 2, and 4. To assess the efficacy, Shirmer’s-1 test, break up time test (BUT), fluorescein stain score, and questioning about ocular symptoms were obtained. To assess the safety, questioning about systemic side effect was obtained. Student-t test was used as a statistical analysis.
Results: :
Shirmer’s-1 test value, 8.5±8.4mm at baseline,change to 7.3±4.0mm (p=0.33), 10.1±8.1 (p=0.33), 8.5±6.6 (p=0.97) in week 1, 2, and 4, respectively. BUT, 2.4±1.5sec at baseline, were significantly increased up to 3.6±1.2sec (p<0.01), 4.4±1.8sec (p<0.01), 4.6±2.0sec (p<0.01) in week 1, 2, and 4, respectively. Fluorescein stain score, 3.2±1.9 at baseline, decreased to 2.8±1.9 (p=0.21), 3.0±2.2 (p=0.02), 2.1±1.8 (p<0.01), in week 1, 2, and 4, respectively. Ocular symptoms improved in 15 cases and remained stable in 12 cases. Ocular discomfort improved in 4 of 8 evaporative dry eye cases. Most of systemic side effects were nausea, hyperhidrosis, increase saliva production, and all symptoms were within the allowance of all participants.
Conclusions: :
Oral pilocarpine is effective in improving the symptoms of patients with both aqueous-deficient dry eye and evaporative dry eye, and is safe for clinical use in Ophthalmology.
Clinical Trial: :
http://www.umin.ac.jp, UMIN000002200
Keywords: cornea: tears/tear film/dry eye