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

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.

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