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R.M. Schiffman, R. Bradford, B. Bunnell, F. Lai, P. Bernstein, S.W. Whitcup; A Multi–Center, Double–Masked, Randomized, Vehicle–Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Testosterone Ophthalmic Solution in Patients With Meibomian Gland Dysfunction . Invest. Ophthalmol. Vis. Sci. 2006;47(13):5608.
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To evaluate the safety and efficacy of testosterone ophthalmic solution compared with vehicle in patients with meibomian gland dysfunction (MGD).
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.
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.
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.
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