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Abstract
Randomized controlled trial evaluating novel keratolytic for MGD treatment
Investigative Ophthalmology & Visual Science, Vol.62(8), 1252
Association for Research in Vision and Ophtamology (ARVO) Annual Meeting, 2021 (Online, 01-May-2021–07-May-2021)
2021
Abstract
Purpose : Ductal epithelial hyperkeratinization is believed to play a key role in the loss of gland function in the development of meibomian gland dysfunction (MGD). This study evaluates a novel topical keratolytic therapy (selenium disulphide) for MGD and associated evaporative dry eye disease (DED).
Methods : Participants with MGD were randomly assigned (1:1) twice weekly, evening application of either AZR-MD-001 0.5% ointment (Azura Ophthalmics) or AZR-MD-001 vehicle, in a multicenter, investigator-masked, vehicle-controlled, randomized, parallel group study (trial registration # NCT04391959). The main outcome measures compared between the active compound and vehicle, include Meibomian Gland Score (MGS), the number of meibomian glands yielding lipid secretion under application of 1.25g/mm2 pressure (Meibomian Gland Evaluator, J&J Vision), and Ocular Surface Disease Index (OSDI) symptom score.
Results : Between July and October 2020, 30 participants (50% female) were enrolled. Mean (SD) participant age on enrolment was 58 (17) years and 64% had been diagnosed with MGD at least 5 years previously. Baseline MGS was 6.34 (3.92) and OSDI score was 38.2 (10.8). Seven patients discontinued; 1 for tolerability issues (burning on application) and 6 for protocol violations. All other participants completed the Month 1.5 visit. Data unmasking to allow full analysis follows the final Month 3 visit for the last participant in early January 2021.
Conclusions : Uniquely targeting hyperkeratinisation as a root cause of MGD, this novel topical pharmacotherapy demonstrates potential to alter meibomian gland function and symptoms associated with DED secondary to MGD. Reported ocular surface outcomes of this trial, revealed following unmasking, represent the first level 1 scientific evidence to consider the efficacy of AZR-MD-001 0.5% in treating MGD.
Details
- Title
- Randomized controlled trial evaluating novel keratolytic for MGD treatment
- Authors
- Jennifer P Craig (Author) - University of AucklandFiona Stapleton (Author) - UNSW AustraliaJacqueline Tan (Author) - UNSW AustraliaSusan Thackwray (Author) - University of the Sunshine Coast, Queensland, School of Health and Sport Sciences - LegacyJagrut Lallu (Author) - University of AucklandScott A Read (Author) - Queensland University of TechnologyKarien Nel (Author) - University of AucklandCharles Bosworth (Author) - Azura Ophthalmics (Victoria, Australia)
- Publication details
- Investigative Ophthalmology & Visual Science, Vol.62(8), 1252
- Conference details
- Association for Research in Vision and Ophtamology (ARVO) Annual Meeting, 2021 (Online, 01-May-2021–07-May-2021)
- Publisher
- Association for Research in Vision and Ophthalmology
- Date published
- 2021
- ISSN
- 1552-5783; 0146-0404
- Organisation Unit
- School of Science and Engineering - Legacy; University of the Sunshine Coast, Queensland; School of Health and Sport Sciences - Legacy
- Language
- Italian
- Record Identifier
- 99549708102621
- Output Type
- Abstract
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