A Randomized Controlled Double-Masked Study of Transdermal Androgen in Dry Eye Patients Associated With Androgen Deficiency

Abstract

To evaluate the efficacy, safety, and quality of life (QOL) of transdermal androgen in treatment of dry eye patients associated with androgen deficiency. Randomized controlled trial. Fifty patients with dry eye from a tertiary eye center in northern Thailand were randomized to receive transdermal androgen (AndroGel; Besins Healthcare, Brussels, Belgium) or placebo for 4weeks. Main outcome measures were symptoms and signs of dry eye. Serum level of sex hormone and QOL questionnaires were also evaluated at the baseline and after treatment. After 4weeks, the Ocular Surface Disease Index decreased significantly in the AndroGel group compared to the placebo (-14.36 ± 7.76 vs 0.14 ± 14.60, P < .001). Significant improvements of tear break-up time (7.40 ± 3.37 vs-1.14 ± 1.68 seconds, P < .001), corneal fluorescein staining (-0.62 ± 0.30 vs 0.19 ± 0.37, P < .001), and Schirmer test (6.84 ± 5.10 vs-0.48 ± 2.14mm, P < .001) were observed in the AndroGel group compared to the placebo. Serum testosterone in female patients significantly increased in the AndroGel group compared to the placebo (P < .001), while no different change was observed in serum testosterone in male subjects and the sex hormone-binding globulin in both groups. In the AndroGel group, 20% of patients had oily skin and 4% had acne. No serious adverse effects were reported. The menopause rating score improved significantly in the AndroGel group compared to the placebo (P < .001), while the aging male symptoms were not different in both groups (P= .589). Transdermal androgen was effective in relieving symptoms and signs of dry eye as well as improving QOL in aging patients. There were no serious side effects during a short-term treatment.