Abstract
Purpose :
To evaluate the safety and efficacy of androgen gel applied to the eyelids to treat patients with moderate to severe dry eye disease.
Methods :
Twenty subjects 18 years of age or older with a diagnosis of moderate to severe dry eye disease according to DEWS II criteria were enrolled in this study. Subjects were randomized to receive either a topical androgen (17β-Hydroxyandrost-4-en-3-one) 4.5% wt./wt. or placebo gel, instructed to apply twice daily 12 hours apart for 4 weeks and were monitored at 2 and 4 weeks. Main outcome measures were symptoms (modified Schein Questionnaire (0 – 24 scale), Ocular Surface Disease Index (OSDI; 0 – 100 scale)) and signs including fluorescein tear breakup time (FTBUT), NEI ocular surface staining (0 – 33 scale), and meibomian gland secretion quality (lower central 8 glands, gentle expression; 0 – 32 scale). A repeated measures ANOVA was conducted for each arm with Tukey comparisons for significant factors if needed.
Results :
10 subjects completed each arm. Significant improvement of FTBUT was observed in the androgen arm after 2- and 4-weeks treatment (3.72 ± 0.9 sec at baseline vs. 5.11 ± 1.2 sec at 2 weeks, p = 0.001, and 5.91 ± 1.0 sec at 4 weeks, p < 0.001). Placebo FTBUT at 2 or 4 weeks was not significantly different (ANOVA; p = 0.373). Meibomian secretion grade in the androgen arm showed significant improvement after 2- and 4-week treatment (16.20 ± 7.7 at baseline vs. 11.5 ± 6.8 at 2 weeks, p = 0.003, and 10.15 ± 5.1 at 4 weeks, p < 0.001). There were no changes in the placebo arm (ANOVA, p = 0.212). Schein symptom score decreased significantly from baseline after 2 and 4 weeks in the androgen arm (10.3 ± 2.3 at baseline vs. 7.5 ± 4.0 at 2 weeks, p = 0.015, and 6.4 ± 4.8 at 4 weeks, p = 0.001), though Schein score also decreased after 4 weeks in the placebo arm (13.32 ± 3.2 vs 8.8 ± 3.4 at 4 weeks, p = 0.015). There were no significant changes in OSDI score or NEI staining after 2- and 4-week treatment in either the androgen or placebo arms (all ANOVA p values > 0.15).
Conclusions :
Topical application of androgen gel was effective in improving tear stability to near- normal levels and in improving meibomian secretion grade in dry eye patients. There was a placebo effect in relieving symptoms of dry eye with gel application to the eyelid. There were no serious side effects during the short-term treatment.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.