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 SETTING: A tertiary eye center in Northern Thailand METHODS: Fifty patients with dry eye were randomized to receive transdermal androgen or placebo for four 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.
After four weeks, the ocular surface disease index decreased significantly in the androgel compared to the placebo (-14.36±7.76 vs 0.14±14.60, p <0.001). Significant improvements of tear break up time (7.40±3.37 vs-1.14±1.68 sec, P<0.001), corneal fluorescein staining (-0.62±0.30 vs 0.19±0.37, P<0.001), and Schirmer test (6.84±5.10 vs. -0.48±2.14 mm, p<0.001) were observed in the androgel group compared to the placebo. Serum testosterone in female patients significantly increased in the androgel compared to the placebo (p<0.001), while no different change was observed in serum testosterone in males and the sex-hormone blinding globulin in both groups. In the androgel group, 20% of oily skin and 4% of acne was found. No serious adverse effects reported. The menopause rating score improved significantly in the androgel group compared to the placebo (p<0.001), while the aging male symptoms were not different in both groups (p=0.589).
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.
American journal of ophthalmology. 2018 Sep 27 [Epub ahead of print]
Sumet Supalaset, Napaporn Tananuvat, Saipin Pongsatha, Winai Chaidaroon, Somsanguan Ausayakhun
Departments of Ophthalmology and Obstetrics and Gynecology., Departments of Ophthalmology and Obstetrics and Gynecology. Electronic address: ., Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.