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

Purpose: To evaluate the efficacy, safety, and quality of life (QOL) of transdermal androgen in treatment of dry eye patients associated with androgen deficiency.

Design: Randomized controlled trial.

Methods: 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 4 weeks. 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.

Results: After 4 weeks, 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 ± 2.14 mm, 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).

Conclusions: 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.