The ocular surface · 2025
A pilot randomized controlled trial of topical androgen treatment in dry eye.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Jiang Jay Ruzhang, Khankan Rima, Ridder William H, Nguyen Andrew Loc, Paugh Jerry R
Аннотация
PURPOSE: To evaluate the safety and efficacy of eyelid androgen gel application to treat moderate to severe dry eye disease.
METHODS: Twenty four eyes of 24 subjects (12 eyes per arm) were randomized to either eyelid testosterone or vehicle gel. Subjects received either 17β-Hydroxyandrost-4-en-3-one) 4.5 % wt./wt. or vehicle gel, applied twice daily 12 h apart for 4 weeks. Outcome parameters were monitored at 2-, and 4-weeks during dosing, and at 4-, and 8-weeks following dosing cessation.
RESULTS: Significant positive differences were found in the androgen arm only, for Schein symptom score, tear meniscus height (TMH), fluorescein tear breakup time (fTBUT) and meibum score (repeated ANOVA, all p = 0.046 or less for each arm comparison) at all follow-up visits compared to baseline. For example, fTBUT in the androgen arm at 4 weeks was 6.2 ± 1.5 s compared to baseline, 3.3 ± 0.9 secs p< 0.001 (Dunnett's test, 95 % CI [1.838, 3.829]). No change was observed for either arm for staining, tear osmolarity, OSDI, non-invasive breakup time (NIBUT), serum lipid levels or hematocrit. Serum testosterone increased ∼ 9-fold in females (paired t-test; p = 0.006; CI [-240.2, -55.6]) in the androgen arm, but not males (paired t-test; p = 0.727; CI [-25.9, 31.2]).
CONCLUSIONS: Eyelid androgen gel application, 4.5 % wt./wt., was effective in improving tear fTBUT, symptoms, TMH and meibomian secretion grade in dry eye patients. Future research requires a larger sample size, outcome measure variability reduction and formulation optimization for absorption, androgen type, and dosing regimen.
METHODS: Twenty four eyes of 24 subjects (12 eyes per arm) were randomized to either eyelid testosterone or vehicle gel. Subjects received either 17β-Hydroxyandrost-4-en-3-one) 4.5 % wt./wt. or vehicle gel, applied twice daily 12 h apart for 4 weeks. Outcome parameters were monitored at 2-, and 4-weeks during dosing, and at 4-, and 8-weeks following dosing cessation.
RESULTS: Significant positive differences were found in the androgen arm only, for Schein symptom score, tear meniscus height (TMH), fluorescein tear breakup time (fTBUT) and meibum score (repeated ANOVA, all p = 0.046 or less for each arm comparison) at all follow-up visits compared to baseline. For example, fTBUT in the androgen arm at 4 weeks was 6.2 ± 1.5 s compared to baseline, 3.3 ± 0.9 secs p< 0.001 (Dunnett's test, 95 % CI [1.838, 3.829]). No change was observed for either arm for staining, tear osmolarity, OSDI, non-invasive breakup time (NIBUT), serum lipid levels or hematocrit. Serum testosterone increased ∼ 9-fold in females (paired t-test; p = 0.006; CI [-240.2, -55.6]) in the androgen arm, but not males (paired t-test; p = 0.727; CI [-25.9, 31.2]).
CONCLUSIONS: Eyelid androgen gel application, 4.5 % wt./wt., was effective in improving tear fTBUT, symptoms, TMH and meibomian secretion grade in dry eye patients. Future research requires a larger sample size, outcome measure variability reduction and formulation optimization for absorption, androgen type, and dosing regimen.