Article ID: EJ20-0178
Androgen regulates the function of lacrimal and meibomian glands, and its deficiency is a pathological factor underlying dry eye disease (DED). However, no androgen has been approved for treating DED due to lack of definite evidence regarding its efficacy and safety in clinics. In this systematic review, we have summarized the clinical studies on the safety and efficacy of androgen replacement therapy (ART) for DED. Medline (via Pubmed), Embase, Clinicaltrials.gov, Wanfang and Chinese Clinical Trials Registry Database were searched for the relevant prospective studies, and 7 studies wherein androgen was applied topically via eye drops or systemically via oral or transdermal administration were included. The quality of these studies was assessed with the Cochrane Collaboration’s tool for assessing risk of bias and methodological index for non-randomized studies. Most studies showed that androgen effectively improved dry eye-related symptoms and increased tear secretion. Furthermore, elderly men and peri-menopausal women with lower levels of circulating androgens responded better to ART. However, one study involving patients with Sjögren’s syndrome showed no improvement in the ART group compared to the placebo control, or to the baseline level. Adverse effects were also common but limited to mild skin problems. In conclusion, androgen is a potential treatment for dry eye disease, especially for people with primary androgen deficiency. Short-term application is relatively safe.