Abstract
Purpose :
To evaluate a novel topical ointment AZR-MD-001 1%, containing selenium disulphide, on ocular signs and symptoms in symptomatic contact lens wearers in a 4 month prospective placebo controlled double masked randomised trial.
Methods :
Symptomatic contact lens wearers (Contact Lens Dry Eye Questionnaire-8 [CLDEQ-8] score >12) with signs of Meibomian Gland Dysfunction (Meibomian Gland secretion score [MGS] ≤12) were enrolled. Participants were randomly assigned to receive either the test AZR-MD-001 1% or vehicle ointment to the lower eyelid margin twice per week (NCT03972501). MGS and number of Meibomian glands yielding liquid secretion (MGYLS) were measured at baseline, after 2, 4, 6 weeks and 2, 3 and 4 months of treatment. CLDEQ-8 was completed at baseline, 1 and 4 months. Differences between active and vehicle were analysed relative to baseline using ANCOVA.
Results :
Fourteen subjects (5 males, 9 females, aged 30.8 ± 13.8 years) completed the study. Compared to baseline, change in MGS significantly improved in the active treatment group after 2 weeks (Mean 3.4 ± 6.1, p<0.05) and continued to improve to four months (19.5 ± 7.6, p<0.0001). In the vehicle group, change in MGS from baseline improved at month 4 (Mean 16 ± 10.1, p<0.005). Compared to baseline, the change in MGLYS was not significant in the active group after 2 and 4 weeks (Mean 0.7 ± 1.8; 2.1 ± 3.4, respectively), but improved after 6 weeks (3.5 ± 3.4, p<0.001) and remained significantly improved by month 4 (3.4 ± 4.1, p<0.001). In the vehicle group, change in MGLYS from baseline was improved at 4 months only. The active reached statistical superiority over the vehicle in both change in MGS and MGLYS at 6 weeks onwards. Both active and control showed a significant improvement in CLDEQ-8 score at 1 and 4 months. At 4 months a larger proportion of subjects using the active (5/7) showed a clinical improvement in CLDEQ-8 score compared with placebo (2/7, p=0.11).
Conclusions :
Use of a topical ointment containing selenium disulphide, designed to treat hyperkeratinisation at the gland orifices, appears to improve Meibomian gland patency and secretion by more than 30% in symptomatic contact lens wearers after six weeks of twice weekly use compared to placebo. Improvements were maintained to 4 months of use. These early findings including improved symptoms warrant further exploration.
This is a 2021 ARVO Annual Meeting abstract.