Abstract
Purpose: :
To evaluate the safety and efficacy of testosterone ophthalmic solution compared with vehicle in patients with meibomian gland dysfunction (MGD).
Methods: :
This study was a multicenter, randomized, double–masked, vehicle–controlled, parallel–group design. Patients (n=179) with MGD and overall ocular discomfort score ≥ 1 and MG secretion quality score ≥ 2 at baseline were randomized to treatment with testosterone ophthalmic solution (0.01, 0.03, or 0.1%) or vehicle for 6 months. Outcome measures included the quality of meibomian gland secretion as rated by the investigator on a scale where 0 = clear excreta, 1 = opaque with normal viscosity, 2 = opaque with increased viscosity, 3 = retain shape (inspissated), and overall ocular discomfort on a scale of 0 (none) to 4 (very severe) reported by the patient at office visits.
Results: :
Patient characteristics at baseline did not differ significantly between groups. The results showed the most effective dose was 0.03% testosterone. Forty–six patients were randomized to 0.03% testosterone and 42 to vehicle. In the ITT population, the percentage of patients that had MG secretions with normal viscosity (grades = 0 or 1) was higher following 6 months of treatment with 0.03% testosterone than with vehicle treatment (44.2% vs. 28.2%; p = 0.055). In patients without inspissated glands at baseline, significantly more patients had normal viscosity after 6 months of treatment with 0.03% testosterone than with vehicle (65.2% vs. 36.0%; p = 0.045). The proportion of patients achieving grade 0 for overall ocular discomfort at month 6 was greater in the 0.03% testosterone group than in the vehicle group for the ITT population (23.3% vs.10.3%; p = 0.085), and for those patients without inspissated glands at baseline, the difference was even greater (30.4% vs. 8.0%; p = 0.060). There were no significant differences in the incidence of adverse effects between the testosterone– and vehicle–treated groups.
Conclusions: :
The results of this exploratory study suggest that treatment of MGD patients with 0.03% testosterone for 6 months is safe, and may improve the quality of meibomian gland secretions and reduce ocular discomfort. Improvement was greater in patients without inspissated glands at baseline. Additional studies in a larger group of patients are warranted.
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • cornea: tears/tear film/dry eye